BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 13673149 · Received March 4, 2022

    Report

    Report Number
    3013756811-2022-21464
    Event Type
    Injury
    Date Received
    March 4, 2022
    Date of Event
    February 12, 2022
    Report Date
    February 12, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. ADDITIONALLY, IT WAS REPORTED THAT A CARTRIDGE ALARM OCCURRED DURING BASAL DELIVERY. IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ELEVATED BLOOD GLUCOSE (BG) LEVEL OF 200-533 MG/DL. CAUSE WAS DUE TO MALFUNCTION INTERRUPTING INSULIN DELIVERY. A MANUAL INJECTION WAS ADMINISTERED TO ADDRESS BG. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1532171 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 19 YR Male Other