Cl II Tandem Diabetes Care t:slim G4 Insulin Pump

Company:Tandem Diabetes Care Inc.
Date of Enforcement Report 7/25/2018
Class lI:

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.
Recall Number: Z-2471-2018

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/MANUFACTURER
Tandem Diabetes Care Inc., San Diego, CA on 4/23/2018. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
55

DISTRIBUTION
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,

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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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