Аналіз інформації за період 01.12.2015 - 31.12.2015, отриманої з іноземних систем повідомлення про продукцію, що становить серйозний ризик




·         GlucoMen LX Sensor test strips used to monitor blood glucose levels - risk of over-estimation

Distributed by Menarini Diagnostics UK - if test strips have been exposed to high humidity, the results can be falsely high (MDA/2015/039)

Alert type: Medical device alert Medical specialism:

Care home staff and 5 othersIssued:21 December 2015

·         Medical device alerts archived in December 2015

A list of all medical device alerts that were archived in December 2015.

Alert type: Medical device alert Issued: 16 December 2015

·         Cardiac Resynchronization Therapy Pacing (CRT-P) - risk of loss of pacing therapy

Manufactured by Medtronic – battery voltage may reduce to a point where the device is no longer able to provide patient pacing therapy - MDA/2015/038

Alert type: Medical device alert Medical specialism:

Anaesthetics and 7 others Issued: 9 December 2015