BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 15160232 · Received August 3, 2022

    Report

    Report Number
    3013756811-2022-80039
    Event Type
    Malfunction
    Date Received
    August 3, 2022
    Date of Event
    July 8, 2022
    Report Date
    July 11, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00853052007271
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNEXPECTED RESET OCCURRED. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 110-156 MG/DL. REPORTEDLY, THE PUMP WAS REPLACED TO RESOLVE THE ISSUE AND THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2033075 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000096 00853052007271

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male