Reported Jul 25, 2018 · Ongoing
t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM Software version: 4.3.4.3, Firmware version: 004722, Firmware, Fuel…
Tandem Diabetes Care Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Tandem Diabetes Care Inc · 11075 Roselle St Ste 200 · San Diego, CA · 92121-1231
Is this the product you have?
- t:slim G4 Insulin Pump with
- Dexcom G4 Platinum CGM Software version4.3.4.3
- Firmware version004722, Firmware, Fuel Gauge, Binary Rev B
- Lot codes and dates
- Serial Numbers
4837314839304839924840134920554923685011575011775011785011875011915012005012025012055012075012685012855013645013685013705013765013855013865013875014325014355014405014435014445014455014665014795014885014905014915014955015035015085015095015195015225015235015265015355015605045225045315045355045405047535049725049905050259047267190488584
- Serial Numbers
- Amount recalled
- 55
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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