FOI release

Freedom of Information on number of PCR tests and Lateral flow test reports received by MHRA during the period 01/01/2020-31/03/2022 (FOI 22/459)

Published 1 June 2022

FOI 22/459

8th March 2022

Dear

Thank you for highlighting the points around the data provided in response to your FOI request.

On review of the data extract, it became clear that you had identified an error. I confirm that there were a number of typing errors which occurred when transferring data from the MHRA database into the tables of data provided to you in our response to your request. Please accept my apologies for these errors, which were unintentional.

Please see below the corrected and updated data tables. I have also taken the opportunity to update February 2022 data to cover the complete month and have included data for the month of March 2022 also.

Notes to understanding the data:

The data is not specific to a particular manufacturer. The number of reports is accurate at the time they were taken from our database on 7th April 2022, and minor changes in the numbers can occur if the reporter of the incident gives us more details later.

The inclusion of a report on our adverse incident database does not necessarily mean the events described were caused by that medical device but could be due to unrelated patient/user factors. Moreover, the information we hold on our database is not a full picture of all the device-related incidents that happened during this period, it is just a snapshot.

Therefore, our data should not be used to make a judgement on the safety of this type of testing device or how likely an adverse incident may occur when using this type of device.

The reason for reporting can be just a suspicion that an incident or adverse effect was caused by a device or the way in which it was being used. Reports might be related to events which resulted in no injury, minor injury or a death or serious deterioration in health or the potential for these events to occur.

It is not compulsory for healthcare professionals and members of the public to report incidents directly to MHRA, but we strongly encourage this.

Total number of reports received in the period 01/01/2020-31/03/2022: 3445

Number of reports received by MHRA during the period 01/01/2020-31/03/2022 broken down by year, month received and type of test. Please note the PCR test data includes sample collection kits:

Month/Year	PCR tests	Lateral flow tests
2020
April	<5	0
May	5	0
June	10	0
July	77	0
August	125	0
September	162	0
October	137	0
November	104	<5
December	97	23
2021
January	110	34
February	138	68
March	119	117
April	100	95
May	91	54
June	150	41
July	117	42
August	98	26
September	172	56
October	133	38
November	136	61
December	169	149
2022
January	105	119
February	45	71
March	29	18

Number of reports received broken down by the year and month they were reported to MHRA and indicating the reported level of harm for PCR tests, this includes the sample collection kits:

Month/Year	None	Minor	Serious	Death
2020
April	0	<5	0	0
May	<5	<5	<5	0
June	9	<5	0	0
July	69	6	<5	0
August	120	<5	<5	0
September	156	<5	<5	0
October	126	10	<5	0
November	90	<5	10	0
December	79	11	7	0
2021
January	76	19	15	0
February	94	27	16	<5
March	99	13	6	<5
April	80	16	<5	0
May	77	10	<5	0
June	130	15	5	0
July	95	19	<5	0
August	84	13	<5	0
September	149	20	<5	<5
October	106	21	6	0
November	111	24	<5	0
December	147	20	<5	0
2022
January	93	9	<5	0
February	42	<5	0	0
March	26	<5	0	0

Number of reports received broken down by the year and month they were reported to MHRA and indicating the reported level of harm for rapid antigen Lateral Flow tests:

Month/Year	None	Minor	Serious	Death
2020
November	<5	0	0	0
December	21	0	<5	0
2021
January	28	5	<5	0
February	51	13	<5	0
March	83	23	11	0
April	74	16	<5	<5
May	41	10	<5	0
June	32	8	<5	0
July	27	15	0	0
August	17	7	<5	0
September	33	19	<5	0
October	25	12	<5	0
November	40	15	6	0
December	132	14	<5	0
2022
January	97	18	<5	0
February	65	<5	<5	0
March	13	<5	<5	0

                                                       Number of reports received indicating the reported clinical effect:

Type of issue reported	PCR tests	Lateral Flow tests
No information provided in the report/Insufficient   information provided to determine clinical effect/could not be determined	2234	991
Headache	0	<5
Hypersensitivity/Allergic reaction	7	7
Choking	8	5
Epistaxis	<5	<5
Respiratory tract infection	0	<5
Sore Throat	<5	<5
Hot flashes/flushes	0	<5
Skin inflammation/irritation	0	<5
Swelling/Edema	<5	<5
No clinical signs, symptoms or conditions reported	131	<5
Loss of consciousness	<5	0
Emotional changes	25	0
Asthma	<5	0
Chronic Obstructive Pulmonary Disorder (COPD)	<5	0
Cough	<5	0
Nasal obstruction	<5	0
Sneezing	<5	0
Vomiting	<5	0
Joint dislocation	<5	0
Foreign body in patient	<5	0
Fluid discharge	<5	0
Reaction to medicinal component of device	<5	0

Number of reports with test kit issues:

Type of issue reported	PCR tests	Lateral Flow tests
Manufacturing, Packaging or Shipping Problem	1300	253
Output Problem	262	364
Patient Device Interaction Problem	161	112
No Apparent Adverse Event	154	94
Material Integrity Problem	144	20
Insufficient Information provided to determine type   of issue	118	26
Mechanical Problem	94	25
Labelling, Instructions for Use or Training Problem	60	15
Adverse Event Without Identified Device or Use   Problem	39	16
Use of Device Problem	25	58
Appropriate Term/Code Not Available	23	12
Contamination / decontamination Problem	16	<5
Computer Software Problem	9	7
No Code Entered By Submitter/Blank	10	5
Infusion or Flow problem		6
Chemical Problem	<5	0
Calibration problem	<5	0
Manufacturing, packaging or shipping problem & Material   Integrity	<5	0
Communication or Transmission problem	<5	0
Manufacturing, packaging or shipping problem &   Mechanical problem	<5	0
Protective measures problem	<5	0
Temperature problem	<5	0
Mechanical problem &Material integrity problem	<5	0

In answer to your specific questions:

• The first table suggests the MHRA received 988 to 992 reports of feedback/harm relating to lateral flow tests in total (uncertainty on exact figure due to the <5 for November 2020). But the third table suggests the MHRA received 1,029 to 1,081 reports that gave information on the level of harm reported (uncertainty due to <5 in table). Could you explain how this is the case? Shouldn’t the second figure should be the same or less than the first figure?

Please review the updated and corrected data tables which I believe will resolve this question.

• Does the fifth table on the number of reports with test kit issues on top of the data in the first table?

The data from the fifth table is taken from the same total number of reports received by MHRA. Reports may include details of test kit issues such as those listed in table 5 and also a number of clinical effects. Some reports contain very minimal data and these may contain blank fields or not enough information to assign a type of test kit issue.

• Or does the first table reflect the total number of PCR and lateral flow reports, and within those multiple harms were reported (which would explain why there are more reports of types of harm than overall reports) and also included reports of test kit issues, which would explain why there are more reports of test kit issues than overall reports?

The first table does reflect the total number of reports received by MHRA. A single report may include a single or a number of reported clinical effects and test kits issues or may contain blank fields or minimal information about the harm or clinical effect or test kit issue which has occurred.

I trust this information and explanation has been of use.

Yours sincerely

MHRA Customer Experience Centre

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU Telephone 0203 080 6000