FDA-Device2025-04-23Class I
Tandem Mobi Insulin Pump with Interoperable Technology
Tandem Diabetes Care, Inc.
Hazard
A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to incorrectly interpolate glucose trends when the Estimated Glucose Value (EGV) is above 255 mg/dL at the start or end of a gap in data collection due to a lapse in connection from a paired continuous glucose monitor (CGM) sensor, which can lead to under-delivery or over-delivery of insulin based on inaccurate result leading to severe cases of hypoglycemia or hyperglycemia.
Sold states
US: 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 OUS: N/A
Affected count
85 units
Manufactured in
12400 High Bluff Dr, San Diego, CA, United States
Products
Tandem Mobi Insulin Pump with Interoperable Technology
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1520-2025Don't want to check this manually?
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