BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 13048061 · Received December 20, 2021

    Report

    Report Number
    3013756811-2021-140458
    Event Type
    Malfunction
    Date Received
    December 20, 2021
    Date of Event
    November 27, 2021
    Report Date
    December 20, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00853052007301
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP USB CABLE GETS HOT TO TOUCH WHEN PLUGGED INTO A POWER SOURCE TO CHARGE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 150-275 MG/DL. REPORTEDLY, THE ISSUE RESOLVED WHEN THE CUSTOMER USED AN ALTERNATE USB CABLE AND ADAPTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1944582 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00853052007301

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male