BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 13950807 · Received March 30, 2022

    Report

    Report Number
    3013756811-2022-29893
    Event Type
    Malfunction
    Date Received
    March 30, 2022
    Date of Event
    March 6, 2022
    Report Date
    March 7, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613793
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 INTERMITTENT OCCLUSION ALARMS OCCURRED. REPORTEDLY, THE CUSTOMER REPLACED THE PUMP SUPPLIES AND RESUMED INSULIN THERAPY. THE CUSTOMER DECLINED FURTHER TROUBLESHOOTING. CUSTOMER'S BLOOD GLUCOSE WAS IN THE RANGE OF 200-279 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2730434 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 30 YR Female INFUSION SET: AUTOSOFT 90INSULIN: HUMALOG