BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 18282140 · Received December 7, 2023

    Report

    Report Number
    3013756811-2023-170483
    Event Type
    Malfunction
    Date Received
    December 7, 2023
    Date of Event
    November 14, 2023
    Report Date
    January 19, 2024
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613793
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, DEVICE EVALUATION IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MULTIPLE INTERMITTENT CARTRIDGE ALARM 1 OCCURRED DURING BASAL DELIVERY . THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 163-206 MG/DL. A CARTRIDGE CHANGE WAS PERFORMED RESOLVING THE ISSUE. ADDITIONALLY, IT WAS REPORTED THAT AN ALTITUDE ALARM OCCURRED WHILE THE CUSTOMER WAS NOT OUTSIDE OF LABELED OPERATING ALTITUDE RANGE. REPORTEDLY THE ALARM ULTIMATELY CLEARED, AND THE CUSTOMER CONTINUED TO USE THE PUMP AND HAS BACK UP MANUAL INJECTIONS FOR CONTINUED INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1086091 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000354 00850006613793

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male