Recall Z-2471-2018— Tandem Diabetes Care Inc
Class II · Ongoing
Class II FDA medical device recall by Tandem Diabetes Care Inc, initiated 2018-04-23. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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..
- Recalling firm
- Tandem Diabetes Care Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2018-04-23
- Firm location
- San Diego, CA, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.