BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 15370385 · Received September 7, 2022

    Report

    Report Number
    3013756811-2022-96508
    Event Type
    Malfunction
    Date Received
    September 7, 2022
    Date of Event
    August 15, 2022
    Report Date
    August 15, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 FILED UPON COMPLETION OF THE EVALUATION.

    Additional Manufacturer Narrative · 0

    REMOVE 4114, 67, AND 3221 FROM ORIGINAL MDR.REMOVE 4114, 67, AND 3221 FROM ORIGINAL MDR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INTERMITTENT ALTITUDE ALARMS OCCURRED. REPORTEDLY, THE PUMP WAS NOT OUTSIDE THE LABELED ALTITUDE OPERATING RANGE. THE CUSTOMER'S BLOOD GLUCOSE WAS APPROXIMATELY 112-138 MG/DL. REPORTEDLY, CUSTOMER WILL CONTINUE TO USE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1431512 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613762

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female