ADVANCE NOTICE Urgent Medical Device Recall Notice – Medsafe Ref #25246
AC Power Adaptors for Tandem t:slim X2 Insulin Pump
01 November 2019
NZMS Diabetes has been advised by Tandem Diabetes Care of a potential safety issue with the A/C power adaptor that was originally supplied with the t:slim X2™ insulin pump.
This issue involves the A/C power adaptor breaking apart, thus exposing the metal prongs contained within the adaptor, which could cause injury if the exposed metal prongs were touched when the adaptor was plugged into an electrical wall outlet.
Tandem has worked in conjunction with the supplier that manufactures the power adaptor to investigate the cause for the defective adaptors, and to implement a change to the manufacturing process to enhance the power adaptors to prevent the issue from recurring. The supplier has implemented corrective actions to resolve the product quality issue and new enhanced adaptors are due to arrive in late November. These will be sent to affected patients automatically when they arrive.
How Does This Affect Current t:slim X2 Insulin Pump users?
Until affected patients receive replacement adaptors, we ask that you maintain care in handling your existing adaptors pending receipt of enhanced replacement adaptors. Always switch off the power socket before attempting to remove the adaptor. It is important that you do not touch any exposed metal prongs while the power socket is live.
On receipt of the replacement adaptors we ask that you immediately discard the original three (3) power adaptors that you received with your pump or accessory kit. The Tandem cable and base plug are not affected by this recall.
If you have changed your address since you went onto your Tandem pump and have not yet notified us of this, please let us know by email firstname.lastname@example.org or call us during office hours on (09) 259 4062
Impacted products and lot numbers
All adaptors. An image of the three adaptors to be disposed of is shown below. An image of the base plug and charging cable to keep is also shown below. DO NOT dispose of the base plug and charging cable – they are not affected by this recall.
This recall is being undertaken after consultation with Medsafe Ministry of Health. Tandem Diabetes Care and NZMS are dedicated to ensuring the highest level of customer support and continue to work to deliver the highest level of quality to our customers. Thank you for your support in this matter and we apologise for any inconvenience caused.