Tandem Mobi Insulin Pump Software Defect Can Cause Incorrect Insulin Dosing
Tandem Mobi and t:slim X2 insulin pumps with Version 7.9 software may deliver incorrect insulin doses due to a glucose-reading defect, risking dangerous high or low blood sugar levels.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA classified this as a Class I recall, meaning the defect poses serious risk of injury or death. The software defect can cause insulin over-delivery or under-delivery, leading to severe hypoglycemia or hyperglycemia, both life-threatening conditions.
Plain-English summary
Tandem Diabetes Care is recalling Tandem Mobi and t:slim X2 insulin pumps with Control IQ+ technology running software Version 7.9.
A software defect causes the pump to incorrectly interpret glucose trend data when the glucose value exceeds 255 mg/dL and there is a gap in data from the continuous glucose monitor. This defect can lead to the pump delivering too much or too little insulin based on inaccurate glucose readings.
Approximately 85 units have been distributed across the United States, including Arizona, California, Colorado, Connecticut, Florida, Hawaii, Iowa, Idaho, Illinois, Indiana, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, Texas, Utah, Virginia, Washington, and Wisconsin.
The recalled product
- Product
- Tandem Mobi Insulin Pump with Interoperable Technology
- Manufacturer
- Tandem Diabetes Care, Inc.
- Category
- Medical Device — Insulin Pump
- Hazard
- software-defect
- incorrect-insulin-delivery
- hypoglycemia
- hyperglycemia
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)
- Software versions 7.9/UDI: 00389152480114
Distribution
Distributed in 29 states:
- AZ
- CA
- CO
- CT
- FL
- HI
- IA
- ID
- IL
- IN
- MD
- ME
- MI
- MO
- MS
- NC
- ND
- NE
- NJ
- NM
- NV
- NY
- OH
- PA
- TX
- UT
- VA
- WA
- WI
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