BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:FLEX INSULIN DELIVERY SYSTEM

    MDR report key: 7241469 · Received February 5, 2018

    Report

    Report Number
    3013756811-2018-02792
    Event Type
    Malfunction
    Date Received
    February 5, 2018
    Date of Event
    January 15, 2018
    Report Date
    February 5, 2018
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K143189
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS BEEN COMPLETED. BASED ON THE ANALYSIS, THE ALLEGED BATTERY CHARGING MALFUNCTION WAS VERIFIED. THE ALLEGED BATTERY DEPLETION MALFUNCTION COULD NOT BE EVALUATED DUE TO DAMAGED USB PINS.

    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 PUMP BATTERY GAUGE DROPPED FROM 95% TO 5% WHILE CONNECTED TO A POWER SOURCE AND A POWER SOURCE ALERT OCCURRED. SUBSEQUENTLY, THE BATTERY FULLY DEPLETED AND THE PUMP SHUT OFF. THE CUSTOMER'S BLOOD GLUCOSE WAS 170-185 (MG/DL). REPORTEDLY THE CUSTOMER HAD AN ALTERNATE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85932 T:FLEX INSULIN DELIVERY SYSTEM INFUSION PUMP LZG TANDEM DIABETES CARE 004628-005

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR