BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:FLEX INSULIN DELIVERY SYSTEM

    MDR report key: 9781128 · Received March 3, 2020

    Report

    Report Number
    3013756811-2020-21899
    Event Type
    Injury
    Date Received
    March 3, 2020
    Date of Event
    February 3, 2020
    Report Date
    March 3, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    UDI-DI
    00852162004576
    PMA / PMN Number
    K143189
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN GAUGE WAS INACCURATE. CUSTOMER¿S BLOOD GLUCOSE REACHED IN RANGE FROM 160-500 MG/DL DUE TO THE FILL ESTIMATE ISSUE. REPORTEDLY, CHANGING THE CARTRIDGES, BLOUSING, AND MANUAL INJECTION WAS APPLIED TO ADDRESSED THE ISSUE. REPORTEDLY, THE CUSTOMER HAD MANUAL INJECTIONS AVAILABLE AS ALTERNATE INSULIN THERAPY UNTIL REPLACEMENT PUMP ARRIVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242766 T:FLEX INSULIN DELIVERY SYSTEM INFUSION PUMP LZG TANDEM DIABETES CARE 004628-005 M112605 00852162004576

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other