Tandem Diabetes Care recalls t:slim G4 insulin pumps with specific software and firmware versions due to potential inaccurate battery readings, which could lead to the pump stopping insulin delivery.
The fuel gauge, the component that reads and reports the battery parameters to the pump, could provide inaccurate readings, which present to the user in one of two ways: A) by triggering a Malfunction 4 Alarm, or B) by triggering a succession of notifications prior to the pump shutting off, including Alert 2 (Battery Low), Alert 3 (Battery Very Low) and Alarm 12 (Battery Very Low). The alarms in both scenarios notify the user that the pump has stopped delivering insulin.
Tandem Diabetes Care is recalling insulin pumps with specific software and firmware versions because the battery gauge might give false readings. This could cause the pump to stop delivering insulin without warning, risking unsafe blood sugar levels.
The fuel gauge in the pump could show inaccurate battery levels, triggering alarms or notifications that the pump has stopped delivering insulin. This might happen without warning, leading to unsafe blood sugar levels if the pump stops working unexpectedly.
People using the t:slim G4 insulin pump with Dexcom G4 Platinum CGM software version 4.3.4.3 and firmware version 004722 are affected. Those with diabetes who rely on this pump for insulin delivery are most at risk.
Check if your pump has software version 4.3.4.3 and firmware version 004722. The serial numbers listed in the recall include numbers like 483731, 483930, and 501157.
Review your pump's software and firmware versions to confirm if they match the recalled versions.
Reach out to Tandem Diabetes Care for guidance on updating the software or firmware.
The fuel gauge in the pump could provide inaccurate battery readings, which might cause the pump to stop delivering insulin without warning.
Check your pump's software and firmware versions. If they match the recalled versions, contact Tandem Diabetes Care for instructions on updating or replacing the pump.
The recall is due to potential inaccurate battery readings that could stop insulin delivery, but the remedy does not specify immediate action to stop use. This is a cautionary recall.
We’ve drafted a message you can send Tandem Diabetes Care to request your refund or repair — edit it as you like.
Subject: Recall Z-2471-2018 — Tandem Diabetes Care Tandem Diabetes Care Hello, I own a Tandem Diabetes Care that is covered by recall Z-2471-2018 from Tandem Diabetes Care. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.