BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP

    MDR report key: 7396326 · Received April 4, 2018

    Report

    Report Number
    3013756811-2018-11957
    Event Type
    Malfunction
    Date Received
    April 4, 2018
    Date of Event
    March 6, 2018
    Report Date
    April 4, 2018
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 PUMP TOUCH SCREEN WAS INTERMITTENTLY UNRESPONSIVE. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, IT WAS CONFIRMED THAT THE PUMP TOUCH SCREEN WAS RESPONSIVE. CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED FROM 150-500 MG/DL. CUSTOMER WOULD CONTINUE TO USE THE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238793 T:SLIM X2 INSULIN PUMP INSULIN PUMP LZG TANDEM DIABETES CARE 1000096

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR