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U.S. Department of Health and Human Services

Class 2 Device Recall t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM

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  Class 2 Device Recall t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM see related information
Date Initiated by Firm April 23, 2018
Create Date July 18, 2018
Recall Status1 Open3, Classified
Recall Number Z-2471-2018
Recall Event ID 79887
PMA Number P140015 
Product Classification Pump, infusion, insulin, to be used with invasive glucose sensor - Product Code OYC
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.
Code Information Serial Numbers: 483731, 483930, 483992, 484013, 492055, 492368, 501157, 501177, 501178, 501187, 501191, 501200, 501202,  501205,  501207,  501268,  501285,  501364,  501368,  501370,  501376,  501385,  501386,  501387,  501432, 501435, 501440, 501443, 501444, 501445, 501466, 501479, 501488, 501490, 501491, 501495, 501503, 501508, 501509, 501519, 501522, 501523, 501526, 501535, 501560, 504522, 504531, 504535, 504540,  504753,  504972,  504990,  505025,  90472671,  90488584 
Recalling Firm/
Manufacturer		 Tandem Diabetes Care Inc
11075 Roselle St Ste 200
San Diego CA 92121-1231
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
Action 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.
Quantity 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,
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = OYC and Original Applicant = Tandem Diabetes Care, Inc.
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