BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 15210269 · Received August 11, 2022

    Report

    Report Number
    3013756811-2022-84308
    Event Type
    Malfunction
    Date Received
    August 11, 2022
    Date of Event
    July 20, 2022
    Report Date
    July 20, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. PER TANDEM'S USER GUIDE: THE PUMP USER GUIDE CAUTIONS THAT INSULIN SHOULD BE AT ROOM TEMPERATURE BEFORE USE OR AIR BUBBLES COULD FORM IN THE CARTRIDGE. V

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INTERMITTENT OCCLUSION ALARMS OCCURRED. THE CUSTOMER'S BLOOD GLUCOSE RANGED FROM 220-290 MG/DL. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT (CTS) IT WAS DISCOVERED COLD INSULIN WAS USED WITHIN THE CARTRIDGE. CTS EDUCATED CUSTOMER ON CARTRIDGE/INSULIN LABELING. REPORTEDLY, THE CUSTOMER CHANGED PUMP SUPPLIES TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2110717 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 25 YR Female INFUSION SET: TRUSTEEL INSULIN: NOVOLOG