BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6028440 · Received October 13, 2016

    Report

    Report Number
    3007981285-2016-14065
    Event Type
    Malfunction
    Date Received
    October 13, 2016
    Date of Event
    September 24, 2016
    Report Date
    September 24, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 A CARTRIDGE ALARM 24 (ATMOSPHERE PRESSURE OUT OF RANGE) OCCURRED AFTER THE PUMP WAS DROPPED. THE CUSTOMER RECEIVED THE SAME ALARM WHEN LOADING A NEW CARTRIDGE. THE CUSTOMER DECLINED TO PROVIDE A BLOOD GLUCOSE LEVEL. IT WAS CONFIRMED THAT THE CUSTOMER HAD MANUAL INJECTIONS AVAILABLE FOR BACKUP INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679800 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628 M018331

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR