Guidance

The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024: examples of incidents to report under the vigilance system

Published 15 January 2025

1. A urinary catheter was used even through the lubricious coating had dried. This may have been due to inadequacies in the labelling. 

Rationale: there is potential for serious injury should the device be used with ineffective lubricious coating. The report should include consideration of whether there is a need to improve the information provided with the device to promote its proper and safe use. 

2. The administration set used with an infusion pump becomes occluded and no therapy is delivered. After some time, the infusion pump alarms to alert the user to the problem.  

Rationale:  the alarm activated after the hazardous situation had already occurred.   

3. A patient with end stage renal failure passes away during haemodialysis treatment. The manufacturer is unable to determine whether there is any fault with the device or whether the death of the patient could be linked to the treatment.  

Rationale: if, after becoming aware of a potentially reportable incident, it is unclear whether the event meets the reporting criteria, the manufacturer must still submit a report within the relevant timeframe. If it is later found to be non-reportable, this can be documented in the final report. 

4. A continuous glucose monitoring device does not alert the user when their glucose level becomes dangerously high or dangerously low. The user feels unwell and self-administers insulin or glucose/sugar to avoid harm. 

Rationale:  as the device did not function correctly, serious deterioration in health was only avoided due to the action of the user. 

Not all adverse incidents result in death or a serious deterioration in health. (defined in Medical devices: post-market surveillance requirements). This may have been avoided because of the particular circumstances, or due to intervention by a user or patient, including self-administered treatment. Such treatment could be in the form of medication, first aid or other form of self help. It is sufficient that if the incident were to occur again, it could have resulted in a serious deterioration in health if the patient, the healthcare professional or other individuals had not taken the same action.  

5. The audible alarm on a ventilator fails to sound to alert the user to a technical fault. The user is alerted to the situation later once the patient’s condition has deteriorated, and a visual alarm alerts them to the situation. 

Rationale: there is potential for serious injury should the device fail to alarm in a hazardous situation.   

6. In silico analysis against emerging pathogen variants carried out by an in vitro diagnostic (IVD) manufacturer shows potential negative impact to the sensitivity of the IVD.  

Rationale: there is potential for false results from the IVD. The manufacturer should investigate this using suitable biological reference materials or clinical material to identify whether there is an impact on the IVD performance. 

7. A self-test IVD has given a false negative, false positive or discrepant result. For example, an IVD for HIV produces a false negative result, meaning the user may then inadvertently spread HIV or may not receive appropriate treatment.  

Rationale: all false results should be reported to the MHRA, regardless of whether other IVDs, clinical tests or medical opinions would be used to make the final patient diagnosis. The manufacturer should carry out post market surveillance (including in silico testing, review of customer feedback and complaints, and validation of the IVD) to ensure the characteristics and performance of the IVD do not adversely affect the safety of the patient or user. 

8. A software IVD has incorrectly read the diagnostic result from a SARS-CoV-2 lateral flow test, resulting in a false result which may impact the user’s behaviour and treatment. 

Rationale: all false results should be reported to the MHRA, regardless of whether other IVDs, clinical tests or medical opinions would be used to make the final patient diagnosis. 

9. A user misassembles a breathing circuit for a ventilated patient. As a result, pressure builds up in the circuit to an unexpected level. 

Rationale: the event could result in serious deterioration of health. The report should include consideration of shortcomings related to the device design, difficulty in using the device safely, and whether there is a need to improve the information provided with the device to promote its proper and safe use. 

Incidents occurring as a result of use error need to be reported if they meet the vigilance reportability criteria regardless of whether the incident has resulted in a serious deterioration in health.  

10. A sub-acute myocardial infarction (MI) occurred following implantation of a coronary stent, resulting in need for additional emergency clinical intervention. MI is one of the recognised potential adverse incidents listed in the associated instructions for use that is associated with use of this type of device. 

Rationale: the event resulted in serious deterioration in health. The reportability status of an incident is not dependant on whether it is listed as a potential adverse event in the instructions for use.   

11. A powered scooter tips whilst driving down a kerb, causing the user to fall. The height of the kerb was slightly more than the maximum safe kerb height quoted in the instructions for use. 

Rationale: the event could result in serious deterioration of health as a result of the fall.  

12. A person falls from a sling during transfer from a bed due to a faulty clip. There may have been inadequacies in the pre-use check guidance.

Rationale: there is potential for serious injury as a result of a fall. The investigation should include consideration of whether there is a need to improve the information provided with the device to promote its proper and safe use, as well as any design or manufacturing problems leading to the faulty clip. 

13. A needle-free connector is used with a pre-filled syringe. The connector is not compatible, and it breaks, leading to a delay in delivering the medication. The inappropriate use may have been due to inadequacies in the instructions for use.

Rationale: there is potential for serious injury as a result of the delay in administration.  The investigation should include consideration of whether there is a need to improve the information provided with the device to promote its proper and safe use. 

14. A critical care machine alarms following a disconnection. The alarm limits are accidentally altered due to unfamiliarity with the user interface and the user does not realise that the blood line has become disconnected, resulting in loss of blood.  

Rationale: the event has the potential to result in serious deterioration in health.   

15. The fluid in a bag of cell storage solution is a slightly different colour to the solution in other bags. The instructions for use state that the solution should not be used if contamination is evident but is not clear on how this should be identified. 

Rationale: there is potential for serious injury as a result of the contamination. The investigation should include consideration of the type of contamination, the causes of the contamination, and the impact use of a contaminated device could have. It should also include consideration of whether there is a need to improve the information provided with the device to promote its proper and safe use. 

16. A delayed use vascular graft is accidentally inserted instead of a rapid access graft. The packaging on both products is similar. 

Rationale: because the wrong type of vascular graft was inserted, the patient would need to have additional surgical procedures which may not have otherwise been needed. The report should include consideration of whether there is a need to improve the information provided with the device to promote its proper and safe use. 

17. A patient using an infusion pump at home turns the pump off and on again when it alarms for occlusion rather than clearing the cause of the occlusion or replacing the set as per the instructions for use. Therapy is not delivered as a result. 

Rationale: there is potential for serious deterioration in health should the infusion not be delivered. 

18. Remote monitoring of vital signs in mental health hospitals and care homes could lead to delay to diagnosis and treatment if it fails to detect the correct physiological parameters, for example, pulse rate, respiratory rate, and oxygen saturation. 

Rationale: there is potential for serious deterioration in health as a result. 

19. AI tools intended to identify or assist in identifying ‘normal’ x-rays miss an abnormality leading to an incorrect, delayed or missed diagnosis.  

Rationale: there is potential for serious deterioration in health as a result of use of the erroneous result. 

20. Compatibility issues arise from operating system updates for continuous glucose monitoring (CGM) apps resulting in loss of ability to see real time data leading to inappropriate or absence of treatment or a delay in diagnosis. 

Rationale: there is potential for serious deterioration in health as a result. 

21. A patient experiences a skin reaction or allergic reaction following use of a medical device. 

Rationale: there is potential for serious injury and deterioration in health of a patient experiencing a serious reaction (for example,anaphylaxis). This includes adverse reactions where a possible irritant is labelled, as despite risk control options in place, a reportable event has still occurred. 

22. A medical device is subject to unintended material degradation when used as intended. 

Rationale: this could lead to exposure to hazardous chemicals and/or particulates resulting in potential harm.  

23. During an interventional procedure, the device does not perform as expected. This was not an out-of-box failure and the problem was not identified before using the device. The patient is not harmed at the end of procedure. 

Rationale: there was a potential for procedural complication and serious harm to the patient. If, after becoming aware of a potentially reportable incident, it is unclear whether the event meets the reporting criteria, the manufacturer must still submit a report within the relevant timeframe. If the investigation later finds that the root cause of the performance issue is related to patient specific anatomy rather than a device defect, this can be documented in the final report. 

24. An x-ray device fails to terminate an exposure resulting in unintended exposure of ionising radiation to the patient. 

Rationale: there is potential for serious deterioration in health as a result of overexposure to ionising radiation.  

25. Failure in a radiation treatment planning software device results in an incorrect radiotherapy treatment dose. 

Rationale: there is potential for serious deterioration in health or patient harm due to incorrect therapeutic dose being delivered. Delivery of incorrect therapeutic dose to target area could result in under or overexposure of radiation to the patient. This could lead to a serious deterioration in health or patient harm (for example, disruption of treatment pathway, exposure to higher levels of radiation, ineffective dosing to target tumour or radiation burns). 

26. Failure of PACS (picture archiving and communications system) to allow timely access to patients imaging data results in a delay to diagnosis. 

Rationale: there is potential for serious injury as a result of the delay in diagnosis or treatment. Unexpected downtime or failure to rapidly access patient information can also lead to repeated imaging procedures and unnecessary radiation exposure.  

27. A device is returned for examination by the manufacturer and a definitive root cause of the reported problem cannot be determined. 

Rationale: the reportability status of an incident is not dependant on whether the root cause can be positively identified. 

28. A reportable incident occurs but the device is not returned to the manufacturer for examination. 

Rationale: the reportability status of an incident is not dependant on the availability of the device for investigation. 

29. The manufacturer is aware of an increase in the frequency or severity of foreseeable or expected events. 

Rationale: a changing pattern of foreseeable or expected events is reportable as a trend.  Individual events in the trend report may or may not be reportable under vigilance.