BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:FLEX INSULIN DELIVERY SYSTEM

    MDR report key: 7770890 · Received August 9, 2018

    Report

    Report Number
    3013756811-2018-29326
    Event Type
    Malfunction
    Date Received
    August 9, 2018
    Date of Event
    July 19, 2018
    Report Date
    August 9, 2018
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    UDI-DI
    00852162004385470908
    PMA / PMN Number
    K143189
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN ADDITIONAL LOT NUMBER WAS REPORTED (LOT #M021098 ). 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 CHANGE ERROR MESSAGES OCCURRED WITH MULTIPLE CARTRIDGES DURING THE LOADING PROCESS. BLOOD GLUCOSE LEVEL WAS 134 MG/DL. IT WAS CONFIRMED THAT THE CUSTOMER HAD MANUAL INJECTIONS AVAILABLE FOR ALTERNATE INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609157 T:FLEX INSULIN DELIVERY SYSTEM INFUSION PUMP LZG TANDEM DIABETES CARE 004628-005 M021266 00852162004385470908

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR