BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 17134482 · Received June 15, 2023

    Report

    Report Number
    3013756811-2023-82179
    Event Type
    Injury
    Date Received
    June 15, 2023
    Date of Event
    May 24, 2023
    Report Date
    June 15, 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 OCCLUSION ALARMS OCCURRED. THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL WAS 170-323 MG/DL AND REPORTEDLY A BG LEVEL READING "HIGH", A SPECIFIC VALUE WAS NOT PROVIDED. ELEVATED BLOOD GLUCOSE WAS ADDRESSED WITH A CORRECTION BOLUS VIA THE PUMP. THE CUSTOMER CHANGED SUPPLIES AND RESUMED INSULIN THERAPY. A SYSTEMS CHECK WAS STARTED WITH TANDEM TECHNICAL SUPPORT, HOWEVER, THE CUSTOMER DECLINED TO COMPLETE THE CHECK., THEREFORE NO ADDITIONAL INFORMATION WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1875478 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 21 YR Female INFUSION SET: AUTOSOFT 90INSULIN TYPE: HUMALOG