BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6807565 · Received August 21, 2017

    Report

    Report Number
    3007981285-2017-23537
    Event Type
    Malfunction
    Date Received
    August 21, 2017
    Date of Event
    July 24, 2017
    Report Date
    August 21, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 THE CUSTOMER RECEIVED MULTIPLE, INTERMITTENT CARTRIDGE ALARMS (CARTRIDGE ALARM 19) WITH MULTIPLE CARTRIDGES DURING BASAL DELIVERY. REPORTEDLY, AFTER ONE OF THE CARTRIDGE ALARMS, THE CUSTOMER REMOVED INSULIN FROM THE CARTRIDGE AND OBSERVED WHITE PRECIPITANTS. THE WHITE PARTICLES WERE NOT SEPTUM MATERIAL AND MAY HAVE BEEN DUE TO INSULIN DEGRADATION. THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL RANGED BETWEEN 171-223 MG/DL. REPORTEDLY, THE CUSTOMER REVERTED TO ALTERNATE THERAPY FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588984 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628 M019540

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR