BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 11790878 · Received May 7, 2021

    Report

    Report Number
    3013756811-2021-49689
    Event Type
    Injury
    Date Received
    May 7, 2021
    Date of Event
    April 8, 2021
    Report Date
    May 7, 2021
    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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CARTRIDGE WAS LEAKING; AS CUSTOMER "MAY HAVE PIERCED THE BAG." SUBSEQUENTLY, THE CUSTOMER EXPERIENCED AN ELEVATED BLOOD GLUCOSE LEVEL RANGE OF 934-938 MG/DL, DIABETIC KETOACIDOSIS, AND WAS ADMITTED TO THE HOSPITAL. THE CUSTOMER WAS TREATED WITH INTRAVENOUS SALINE AND INSULIN AND RELEASED ON (B)(6) 2021 WITH NO PERMANENT DAMAGE. REPORTEDLY, THE CUSTOMER LOADED A NEW CARTRIDGE AND CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689564 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 51 YR Hospitalization| R