BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 16514393 · Received March 9, 2023

    Report

    Report Number
    3013756811-2023-29666
    Event Type
    Malfunction
    Date Received
    March 9, 2023
    Date of Event
    February 16, 2023
    Report Date
    March 9, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 THE INSULIN GAUGE WAS INACCURATE AND STATIC. CUSTOMER CONTINUED TO USE THE EXISTING CARTRIDGE FOR INSULIN DELIVERY. ADDITIONALLY, IT WAS REPORTED THAT AN OCCLUSION ALARM OCCURRED. REPORTEDLY, MULTIPLE SUPPLY CHANGES WERE PERFORMED RESOLVING THE OCCLUSION. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 230-269 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706582 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 W0793479 00850006613762

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male INSULIN: HUMALOGINFUSION SET: AUTOSOFT XC