The Australia Therapeutic Goods Administration (TGA) posted a medical device safety alert concerning Accu-Chek Spirit Combo Insulin Pumps manufactured by Roche Diagnostics.
The manufacturer has become aware that in a limited number of cases, patients using the Accu-Chek Spirit Combo insulin pump may experience a loss of the date and time settings. Investigation of the situation revealed that this issue may occur if the pump capacitor fails to function properly due to a leakage. The capacitor provides the necessary voltage to save time and date settings during power interruption, typically during a battery change.
The manufacturer is advising end users and healthcare professionals of the potential issue. End users are advised to ensure that the time and date are set correctly after a battery change. Users who experience any failures are requested contact the manufacturer to arrange for a replacement pump.
According to the local supplier, the affected products were not distributed in Hong Kong.
For details, please refer to the following link:
http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01063-1
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 03 October 2014