BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6074423 · Received November 2, 2016

    Report

    Report Number
    3007981285-2016-17064
    Event Type
    Malfunction
    Date Received
    November 2, 2016
    Date of Event
    October 13, 2016
    Report Date
    October 13, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PATIENT

    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 MULTIPLE CARTRIDGE ALARMS (CARTRIDGE ALARM 19) OCCURRED WITH MULTIPLE CARTRIDGES DURING THE LOAD PROCESS. THE USER'S BLOOD GLUCOSE LEVEL WAS 144 MG/DL. IT WAS CONFIRMED THAT THE USER HAD AN ALTERNATE METHOD OF INSULIN DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723995 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR