BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:FLEX INSULIN DELIVERY SYSTEM

    MDR report key: 7620475 · Received June 20, 2018

    Report

    Report Number
    3013756811-2018-20339
    Event Type
    Injury
    Date Received
    June 20, 2018
    Date of Event
    June 1, 2018
    Report Date
    June 20, 2018
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K143189
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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, INTERMITTENT CARTRIDGE ALARMS (ALARM 1) OCCURRED WITH MULTIPLE NEW CARTRIDGES. BLOOD GLUCOSE LEVEL RANGED BETWEEN 200-492 MG/DL. DUE TO THE CARTRIDGE ALARMS, THE CUSTOMER WAS ADMITTED TO THE EMERGENCY ROOM (ER) WITH A BG LEVEL OF 492 MG/DL AND LARGE KETONES. WHILE IN THE ER, THE CUSTOMER RECEIVED TREATMENT IN THE FORM OF INTRAVENOUSLY DELIVERED FLUIDS AND AN INSULIN DRIP. CUSTOMER'S BG LEVEL WAS 200 MG/DL AFTER TREATMENT. REPORTEDLY, THE CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462431 T:FLEX INSULIN DELIVERY SYSTEM INFUSION PUMP LZG TANDEM DIABETES CARE 004628-005 M021176

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention