Insulin pump app may crash and drain battery, risking insulin delivery interruption
Tandem's t:connect app version 2.7+ may crash repeatedly, draining the insulin pump battery faster than expected and potentially interrupting insulin delivery.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I medical device recall, which per rubric guidelines never scores below 4. The hazard involves device malfunction (repeated crashes, battery drain, and shutdown) that could suspend delivery of life-sustaining insulin therapy. Although no illnesses or injuries have been reported, the risk to insulin-dependent patients warrants a Severe classification.
Plain-English summary
Tandem Diabetes Care is recalling the t:connect mobile app (version 2.7 or later) used with the t:slim X2 insulin pump with Control-IQ technology. During normal use, the app may crash and be automatically relaunched by iOS, creating a cycle of repeated crashes that causes excessive Bluetooth communication between the app and the pump.
This excessive Bluetooth activity drains the pump battery faster than normally expected. As a result, the pump may shut down sooner than anticipated, which causes insulin delivery to suspend.
Suspended insulin delivery could result in insulin under-delivery and hyperglycemia, including severe hyperglycemia. Approximately 85,863 applications of the app have been distributed nationwide in the US, including Puerto Rico. No illnesses or injuries have been reported to date.
The recalled product
- Product
- t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
- Manufacturer
- Tandem Diabetes Care, Inc.
- Affected units
- 85,863
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- version 2.7 or later /UDI: 00850006613274
Distribution
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