BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP)

    MDR report key: 20051254 · Received August 23, 2024

    Report

    Report Number
    3013756811-2024-158572
    Event Type
    Injury
    Date Received
    August 23, 2024
    Date of Event
    July 30, 2024
    Report Date
    July 21, 2025
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    PMA / PMN Number
    K203234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 A BLOOD GLUCOSE (BG) LEVEL OF 251-325 MG/DL; CAUSE WAS DUE TO NOT HAVING ANY BACKUP METHODS OF INSULIN DELIVERY AFTER THE PUMP EXPERIENCED A MALFUNCTION ALARM. CUSTOMER ADMINISTERED A MANUAL INJECTION TO ADDRESS BG LEVEL. THE CUSTOMER WAS ADMITTED INTO THE EMERGENCY ROOM AND TREATED WITH INTRAVENOUS SALINE AND INSULIN FLUIDS. CUSTOMER WAS RELEASED FROM THE HOSPITAL ON JULY 31ST, 2024, WITH THE ISSUE RESOLVED. CUSTOMER DID NOT SUSTAIN ANY PERMANENT DAMAGE. A SYSTEM CHECK WAS PERFORMED, AND NO ISSUES WERE IDENTIFIED WITH THE CARTRIDGE, INFUSION SET TUBING, INFUSION SET CANNULA, OR THE INSULIN IN USE AT THE TIME OF EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1527409 T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP) ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown INSULIN TYPE: NOVOLOG / NOVORAPID.