Tandem Diabetes Care Inc recalls t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM Software version: 4.3.4.3, Firmware version: 004722, Firmware, Fuel…

Recall date

April 23, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2471-2018

FDA classification

Class II

Brand / firm

Tandem Diabetes Care Inc

Sold / distributed

U.S. Consignees: IN, AZ, UT, TX, NY, NJ, MD, MN, IL, CO, AL, WI, CA, PA, OH, OR, MS, FL, NM, ID, NV, KY, VA,

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM Software version: 4.3.4.3, Firmware version: 004722, Firmware, Fuel Gauge, Binary Rev B.