t:slim X2 Insulin Pump Software Defect Affecting Glucose Delivery
Tandem Diabetes Care is recalling 63 units of the t:slim X2 Insulin Pump with software version 7.9 due to a defect that can cause incorrect insulin delivery. The defect may lead to dangerous blood sugar levels when glucose monitoring loses connection.
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: The FDA classified this as a Class I recall of a medical device that can cause severe hypoglycemia or hyperglycemia due to incorrect insulin delivery. Class I medical device recalls with risk of serious harm are scored as Severe (4) when no deaths are reported.
Plain-English summary
Tandem Diabetes Care, Inc., is recalling the t:slim X2 Insulin Pump with Interoperable Technology (software version 7.9, UDI 00389152407012) due to a software defect that affects insulin delivery accuracy. The defect occurs when the pump is used with Control IQ+ technology and loses connection with a continuous glucose monitor (CGM) sensor while the glucose reading is above 255 mg/dL. In these situations, the pump incorrectly calculates glucose trends, which can result in under-delivery or over-delivery of insulin.
This software defect can lead to severe cases of hypoglycemia (dangerously low blood sugar) or hyperglycemia (dangerously high blood sugar) because the insulin dosing is based on inaccurate glucose information. Approximately 63 units have been distributed across multiple U.S. states including Arizona, California, Colorado, Connecticut, Florida, Hawaii, Idaho, Illinois, Indiana, Iowa, Maine, Maryland, Michigan, Missouri, Mississippi, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Pennsylvania, Texas, Utah, Virginia, Washington, and Wisconsin.
Patients using the affected pumps should contact Tandem Diabetes Care for guidance. Tandem will provide a software update to correct the defect. Users should not discontinue insulin therapy without medical advice.
The recalled product
- Product
- t:slim X2 Insulin Pump with Interoperable Technology
- Manufacturer
- Tandem Diabetes Care, Inc.
- Hazard
- insulin-delivery-error
- hypoglycemia
- hyperglycemia
- software-defect
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: 00389152407012
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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