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.

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.

On 04/23/2018, customers were sent Urgent Medical Device Voluntary Recall letters via overnight mail delivery and email. The letter instructed customers to call Customer Support at 1-877-801-6901 to arrange for replacement pumps. Customers were advised to continue using effected devices provided they kept Emergency Kits with backup insulin supplies with them. If customers noted unexpected battery behavior, malfunction 4 alarm, or the following alerts: Alert 2 (Battery Low), Alert 3 (Battery Very Low) and Alarm 12 (Battery Very Low), then customers were advised to discontinue use and use backup insulin supplies, while they waited for replacement pumps. The firm advised customers to fill out and return via fax, email, or mail Medical Device Recall Return Response forms.