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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TANDEM DIABETES CARE T:FLEX INSULIN DELIVERY SYSTEM; INFUSION PUMP
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TANDEM DIABETES CARE T:FLEX INSULIN DELIVERY SYSTEM; INFUSION PUMP Back to Search Results
Model Number 004628-005
Medical Device Problem Code Charging Problem (2892)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 11/02/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation; however, device evaluation is not yet complete.A supplemental report will be filed upon completion of the evaluation.
 
Event or Problem Description
It was reported that the pump battery could not be charged.Customer¿s blood glucose level was 360 mg/dl.The customer reverted to an alternate method of insulin therapy.
 
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Brand Name
T:FLEX INSULIN DELIVERY SYSTEM
Common Device Name
INFUSION PUMP
Manufacturer (Section D)
TANDEM DIABETES CARE
11075 roselle street
san diego CA 92121
MDR Report Key10875626
Report Number3013756811-2020-129723
Device Sequence Number3315632
Product Code LZG
UDI-Device Identifier00852162004606
UDI-Public(01)00852162004606
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K143189
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 11/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Device Model Number004628-005
Device Catalogue Number007666
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/17/2020
Was the Report Sent to FDA? Yes
Initial Date Received by Manufacturer 11/03/2020
Supplement Date Received by Manufacturer12/18/2020
Initial Report FDA Received Date11/20/2020
Supplement Report FDA Received Date12/21/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age63 YR
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