BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 15826310 · Received November 18, 2022

    Report

    Report Number
    3013756811-2022-128535
    Event Type
    Malfunction
    Date Received
    November 18, 2022
    Date of Event
    October 26, 2022
    Report Date
    December 9, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613793
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INTERMITTENT MALFUNCTION ALARMS OCCURRED. THE CUSTOMER DID NOT HAVE AN ALTERNATE METHOD OF INSULIN THERAPY AVAILABLE. MULTIPLE ATTEMPTS WERE MADE BY TANDEM TECHNICAL SUPPORT TO CONFIRM AN ALTERNATIVE METHOD OF INSULIN THERAPY WAS OBTAINED; HOWEVER NO RESPONSE WAS RECEIVED. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 200 - 223 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231073 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 61 YR Male