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滨苍迟谤辞诲耻肠迟颈辞苍听听

This document provides guidance for manufacturers of devices for IVD blood glucose monitors, covering point of care testing and home use. It outlines specific scenarios to consider when determining if an incident is reportable, and what to include in the report.听聽

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

The aim of this guidance is to complement the requirements of . You should read it in conjunction with this regulation. Device-specific guidance does not replace or extend these requirements.听

1. What to report聽

The UK national regulations require manufacturers to notify the relevant competent authority if:聽

• they know of any malfunction or deterioration in the characteristics and/or performance of the device for the measurement of blood glucose, as well as any inadequacy in the labelling or the instructions for use which might lead to, or might have led to, the death of a patient or to a serious deterioration in their state of health聽

• the device for the measurement of blood glucose has been involved in any systematic recall for technical or medical reasons connected with a deterioration in their characteristics or performance that could lead to the death or the deterioration in the state of health of a patient聽

Examples of serious adverse incidents include, but are not limited to, the following:聽

1.1 Display issues聽

Serious incidents which resulted from missing segments of the screen, failure of the screen to display the result, or a complete failure of the screen to display at all, are reportable.听聽聽

1.2 Performance issues聽

A serious incident resulting from the failure to perform according to the performance characteristics specified in the information provided by the manufacturer is reportable.听

Any incorrect test results that caused, or contributed to, an incorrect or missed patient diagnosis and/or treatment are reportable. These may result from imprecision,聽

falsely high results, falsely low results, inadequate quality control or inadequate calibration.听

Tools for determining the clinical significance of reported results may be useful ().听

1.3 Use error聽

Serious adverse incidents resulting from use error are reportable (see use error in guidance on post market surveillance)听

1.4 Inadequate labelling and instructions for use聽

Any serious incident which has resulted from inadequate or misleading labelling is reportable. This includes any incident which results from incorrect packaging due to product mix-up.听

Additionally, any serious adverse incident resulting from confusing or inadequate instructions for use is reportable.听

1.5 顿别蝉颈驳苍/尘补苍耻蹿补肠迟耻谤颈苍驳听

Serious incidents resulting from defective product design, or faulty manufacturing of the product, are reportable. Faulty manufacturing processes include, but are not limited聽to, contamination issues, stability problems with quality control solutions or test strips, issues resulting in failure to power-on, and reversion to incorrect units of measurement.听

1.6 Unknown aetiology聽

In some cases, the reason for a serious incident may not be well defined, may involve a number of aetiologies, or may present novel or previously unrecognized factors. In these circumstances, the incident is reportable.听

2 Report 颈苍蹿辞谤尘补迟颈辞苍听

The MHRA expects the following information to be included, if applicable, on each individual adverse incident report submitted by the manufacturer:聽

• test strip model, lot number and expiry date聽

• meter model name and serial number聽

• description of failure (for example, imprecise reading, missing segment, incorrect unit)听

• blood glucose meter readings聽

• patient鈥檚 symptoms including any resultant injury聽

• description of patient鈥檚 testing technique (for example, use of alcohol wipe before testing)听

• patient and/or carer鈥檚 immediate actions (for example, immediate treatment, ambulance called)听

• healthcare worker鈥檚 immediate actions (for example, immediate treatments initiated)听

• manufacturer鈥檚 actions (for example, actions taken to obtain meter and/or test strips)听

• any other relevant 颈苍蹿辞谤尘补迟颈辞苍听

The manufacturer鈥檚 investigation should include, as applicable:聽

• an analysis of the manufacturing records聽

• a post-market surveillance review聽

• stability studies聽

• analysis of the returned product聽

• use of control solutions on retained strips and retained meters聽

• a presentation of the results聽

In addition, the manufacturer should have in place a standard operating procedure describing the actions taken when either no blood glucose meter or no blood glucose meter test strip is returned.听

3 Final vigilance report聽

The final vigilance report should include, as a minimum, the following information:聽

• details of any clinical assessment where the patient鈥檚 condition may have contributed to the adverse incident聽

• manufacturer鈥檚 final assessment, including root cause and details of further follow up with timescales as appropriate聽

• corrective actions taken by the manufacturer