MHRA (the Medicines and Healthcare products Regulatory Agency) have issued a warning to users of insulin pumps which have been manufactured by Tandem Diabetes Care, following reported incidents of an exposed component in the power adaptor which may cause an electrical shock to the user or patient.
A potential safety issue has been identified with the A/C power adapter that was originally supplied along with the t:slim X2 insulin pump. This issue involves the A/C power adapter breaking apart, exposing the metal prongs contained within the adapter, which could cause injury if the exposed metal prongs were touched when the adapter was plugged into an electrical wall outlet.
Tandem has worked in conjunction with the supplier that manufactures the power adapter to investigate the cause for the defective adapters, and to implement a change to the manufacturing process to enhance the power adapters to prevent the issue from recurring.
Devices and Adapters Affected
Device Type: Ambulatory Insulin Infusion Pump, Electronic
Commercial Name(s): t:slim X2 insulin pump Dexcom G5™ Mobile CGM enabled; t:slim X2 insulin pump with Basal-IQ™ technology
Unique Device Identifier(s) (UDI-DI): 00853052007806, 00850006613021; 00853052007820, 00850006613052
Device Model / Part Number(s): 1002684, 1004223; 1002744, 1004227
Affected Serial Number Range: All t:slim X2 insulin pumps distributed internationally
MHRA has issued the following actions for users of the insulin pumps:
Please discard or destroy the three (3) power adapters that you received when you initially received your Tandem insulin pump. We ask that you go to https://qrgo.page.link/xGoyu or scan the QR code in the safety notice below to complete a short online form for us to maintain records of the disposal process.
Click here to download the full field safety notice for more information.
For more information, contact Air Liquide Homecare:
- Tel: 0800 012 1560
- Email: firstname.lastname@example.org
Alternatively, you can contact your diabetes team for advice.