Guidance

Device-specific vigilance guidance: insulin infusion pumps and integrated meter systems

Published 15 January 2025

Introduction  

This document provides guidance for manufacturers of insulin infusion pumps and integrated meter systems. It outlines specific scenarios to consider when determining if an incident is reportable.  

The scope of this DSVG includes insulin infusion pumps and integrated meter systems (insulin infusion pumps operating in combination with a blood glucose monitoring system). Continuous glucose monitoring devices are not included in the scope of this DSVG, nor are associated devices such as infusion sets and/or cartridges.  

You should read this document in conjunction with guidance on post-market surveillance. 

The aim of this guidance is to complement the requirements of SI 2024 No. 1368. You should read it in conjunction with this regulation. Device-specific guidance does not replace or extend these requirements. 

What to report 

The following examples indicate how to report device performance problems that caused or contributed to an incident. The examples are for illustrative purposes only and do not constitute an exhaustive list. If in an incident appears to meet criteria contained in more than one category, ensure it is included in submissions under each reporting format, even if this results in duplication of reporting for that incident. 

1. Report as individual incidents (in line with reporting timescales) 

Clinical / symptomatic 

• death  

• severe hypoglycaemia / severe hyperglycaemia 

• hypoglycaemia / hyperglycaemia resulting in loss of consciousness / coma 

• hyperosmolar hyperglycaemic state  

• diabetic ketoacidosis 

• unexpected medical intervention by professional or other  

Device (IMDRF Annex A Codes) 

The IMDRF annex codes associated with each text description are included as guides in the following: 

• device alarm system problem (A1601) 

• pumping problem (without prior alarm) (A1412)  

• power problem (without prior alarm) (A0708) 

• unexpected shutdown (without prior alarm) (A0719)  

• electrical power problem (without prior alarm) (A07)  

• excess flow or over-infusion (without prior alarm) (A1402) 

• improper flow or infusion (without prior alarm) (A1405) 

• insufficient flow or under infusion (without prior alarm) (A1407)  

• no flow (without prior alarm) (A1408) 

• incomplete or inadequate connection of associated components (A1207)  

• software problems impacting dosing, function, user interface, safety information and patient status (for example, information about battery status, calibration and blood glucose value) (A11) 

• incorrect, inadequate or imprecise result or readings of blood glucose (resulting in medication error) (A0908)  

• no display / image (sudden onset) (A090206) 

• human-device interface problem (sudden onset) (for example, loss of keypad function) (A22) 

• fluid leak (impacting dosing) (A050401)  

• wireless communication problem (including cybersecurity) impacting dosing, function, user interface, safety information and patient status (for example, information about battery status, calibration and blood glucose value) (A1305)  

• computer system security problem (cybersecurity) impacting dosing, function, user interface, safety information and patient status (for example, information about battery status, calibration and blood glucose value) (A1105)  

2. Incidents that may be included in periodic summary reports (PSR) on agreement 

If you cannot use PSR, then report these events individually: 

• incidents related to field safety corrective actions (FSCAs) following agreement between the MHRA and manufacturer  

Device (IMDRF Annex A Codes) 

The IMDRF annex codes associated with each text description are included as guides in the following: 

• display or visual feedback problem (gradually evolving) (A0902) 

• human-device interface problem (gradually evolving) (for example, keypad failure, degraded keypad) (A22)  

• case break (with potential for serious deterioration in state of health) (A0401)  

• moisture or humidity problem (with potential for serious deterioration in state of health) (A1905)  

• battery compartment crack (with potential for serious deterioration in state of health) (A0404) 

• charging problem (with potential for serious deterioration in state of health) (A0706)  

• incorrect, inadequate or imprecise result or readings of blood glucose (not resulting in a medication error) (A0908)  

• fluid leak (not impacting dosing) (A050401) 

3. Report at the time of a significant increase in the frequency or severity of incidents: 

• all trends in reportable adverse incidents 

Device (IMDRF Annex A Codes) 

• use error (without potential for adverse patient event) (A23)  

• pumping problem (with alarm prior to failure) (A1412)  

• priming problem (with alarm prior to failure) (A1414)  

• power problem (with alarm prior to failure) (A0708) 

• unexpected shutdown (with alarm prior to failure) (A0719)  

• electrical power problem (with alarm prior to failure) (A07) 

• excess flow or overinfusion (with alarm prior to failure) (A1402) 

• improper flow or infusion (with alarm prior to failure) (A1405) 

• insufficient flow or underinfusion (with alarm prior to failure) (A1407) 

• no flow (with alarm prior to failure) (A1408)