BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4844417 · Received June 12, 2015

    Report

    Report Number
    3007981285-2015-33881
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Date of Event
    May 17, 2015
    Report Date
    May 17, 2015
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN REC'D FOR EVAL. SHOULD NEW RELEVANT INFO BE REC'D A SUPPLEMENTAL FORM WILL BE COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER DROPPED THE PUMP AND THE TOUCHSCREEN IS NOW SHATTERED, AND THE WAKE BUTTON IS NO LONGER FUNCTIONAL. THE DEVICE TURNS ON WHEN PLUGGED INTO A POWER SOURCE. THERE WAS NO IMPACT TO THE CUSTOMERS'S BLOOD GLUCOSE LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384130 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR