BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6147415 · Received December 6, 2016

    Report

    Report Number
    3007981285-2016-22497
    Event Type
    Injury
    Date Received
    December 6, 2016
    Date of Event
    November 16, 2016
    Report Date
    November 16, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS BEEN COMPLETED AND THE REPORTED ISSUE WAS CONFIRMED. IN ADDITION, A DIFFERENT ISSUE WAS ALSO FOUND.

    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 SHUT OFF UNEXPECTEDLY. THE PUMP WAS CONNECTED TO A POWER SOURCE AND WAS ABLE TO BE TURNED ON. CUSTOMER REPORTED BLOOD GLUCOSE (BG) LEVEL WAS 350 (MG/DL). AN INSULIN PEN WAS USED TO ADDRESS BG LEVEL. REPORTEDLY THE CUSTOMER HAS MANUAL INJECTIONS AS ALTERNATE INSULIN THERAPY UNTIL THE REPLACEMENT PUMP IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800813 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other