BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 14746896 · Received June 20, 2022

    Report

    Report Number
    3013756811-2022-60412
    Event Type
    Malfunction
    Date Received
    June 20, 2022
    Date of Event
    May 29, 2022
    Report Date
    May 29, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613793
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 AN ALTITUDE ALARM OCCURRED. REPORTEDLY, THE PUMP WAS NOT OUTSIDE THE LABELED ALTITUDE OPERATING RANGE. REPORTEDLY, THE CUSTOMER RELOADED THE CARTRIDGE, AND INSULIN DELIVERY WAS RESUMED. ADDITIONALLY, IT WAS REPORTED THAT AN OCCLUSION ALARM OCCURRED. A SUPPLY CHANGE WAS PERFORMED RESOLVING THE OCCLUSION. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 230-246 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2870539 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 68 YR Female INSULIN: HUMALOGINFUSION SET: TRUSTEEL