BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6837723 · Received September 1, 2017

    Report

    Report Number
    3007981285-2017-25080
    Event Type
    Malfunction
    Date Received
    September 1, 2017
    Date of Event
    August 12, 2017
    Report Date
    September 1, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    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 INTERMITTENT CARTRIDGE ALARMS (CARTRIDGE ALARM 19) OCCURRED WITH MULTIPLE CARTRIDGES DURING BASAL THERAPY. THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL RANGED BETWEEN 163 - 239 MG/DL. REPORTEDLY, CUSTOMER REVERTED TO MANUAL INJECTIONS FOR ALTERNATE INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618235 T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR