BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 10942529 · Received December 3, 2020

    Report

    Report Number
    3013756811-2020-136667
    Event Type
    Malfunction
    Date Received
    December 3, 2020
    Date of Event
    November 16, 2020
    Report Date
    December 3, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613205
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 BATTERY GAUGE WAS FLUCTUATING. ADDITIONALLY, CUSTOMER REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 123-166 MG/DL. REPORTEDLY, ISSUES WERE RESOLVED, AND THE CUSTOMER CONTINUED USING THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1407862 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613205

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR