BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 16643027 · Received March 30, 2023

    Report

    Report Number
    3013756811-2023-43971
    Event Type
    Injury
    Date Received
    March 30, 2023
    Date of Event
    September 24, 2022
    Report Date
    March 30, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    PMA / PMN Number
    K201214
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED, AND EVALUATION IS PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED LOW BLOOD GLUCOSE (BG) LEVELS OF 48-49 MG/DL. THE SUSPECTED CAUSE OF THE LOW BG WAS NOT PROVIDED; HOWEVER, THE CUSTOMER¿S CONTINUOUS GLUCOSE MONITOR VALUE WAS INACCURATELY DISPLAYING 162-163 MG/DL DURING THE EVENT. CUSTOMER CONSUMED CARBOHYDRATES TO ADDRESS BG. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210295 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 5311107

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other