BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 7014518 · Received November 9, 2017

    Report

    Report Number
    3007981285-2017-33403
    Event Type
    Malfunction
    Date Received
    November 9, 2017
    Date of Event
    October 23, 2017
    Report Date
    November 9, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 A CARTRIDGE ALARM (ALARM 19) DURING BOLUS DELIVERY. THE CUSTOMER ALSO RECEIVED MULTIPLE INTERMITTENT CARTRIDGE ALARMS DURING BASAL DELIVERY. THE CUSTOMER'S BLOOD GLUCOSE RANGED FROM 160-325 MG/DL. THE CUSTOMER SUCCESSFULLY LOADED A NEW CARTRIDGE AND CONTINUED TO USE THE PUMP FOR INSULIN DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792348 T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR