BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP

    MDR report key: 7914334 · Received September 27, 2018

    Report

    Report Number
    3013756811-2018-34074
    Event Type
    Malfunction
    Date Received
    September 27, 2018
    Date of Event
    September 16, 2018
    Report Date
    September 27, 2018
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    UDI-DI
    00852162004781524644
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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 COULD NOT BE CHARGED DESPITE THE ATTEMPT OF MULTIPLE WALL ADAPTERS. REPORTEDLY, THE PUMP BATTERY FULLY DEPLETED AND SUBSEQUENTLY THE PUMP SHUT OFF. THE CUSTOMER¿S BLOOD GLUCOSE WAS BETWEEN 103-176(MG/DL). DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, THE CUSTOMER WAS INSTRUCTED TO PLUG THE PUMP INTO A POWER SOURCE FOR AT LEAST 30 MINUTES. CUSTOMER ACKNOWLEDGED. DURING FOLLOW-UP, THE CUSTOMER CONFIRMED THAT THE PUMP HAD TURNED ON AND WAS ABLE TO BE SUCCESSFULLY CHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756827 T:SLIM X2 INSULIN PUMP INSULIN PUMP LZG TANDEM DIABETES CARE 1000096 00852162004781524644

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR