BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP

    MDR report key: 6153392 · Received December 7, 2016

    Report

    Report Number
    3007981285-2016-23539
    Event Type
    Malfunction
    Date Received
    December 7, 2016
    Date of Event
    November 22, 2016
    Report Date
    November 22, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE USER WAS UNABLE TO GET A CARTRIDGE ONTO THE PUMP. REPORTEDLY, THE CARTRIDGE WOULD SLIDE ONTO THE PUMP, BUT WOULD NOT CLICK INTO PLACE. THE USER SUCCESSFULLY LOADED A NEW CARTRIDGE. THE USER'S BLOOD GLUCOSE LEVEL WAS 130 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802033 T:SLIM X2 INSULIN PUMP INSULIN PUMP LZG TANDEM DIABETES CARE 1000096 M018681

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR