BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6178552 · Received December 15, 2016

    Report

    Report Number
    3007981285-2016-25570
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    December 5, 2016
    Report Date
    December 5, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP RESET UNEXPECTEDLY. CUSTOMER REPORTED BLOOD GLUCOSE LEVEL WAS 70-200 (MG/DL). REPORTEDLY THE CUSTOMER WILL USE MANUAL INJECTIONS AS ALTERNATE INSULIN THERAPY UNTIL THE REPLACEMENT PUMP IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827541 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR