BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ+ TECHNOLOGY

    MDR report key: 22751911 · Received August 8, 2025

    Report

    Report Number
    3013756811-2025-188787
    Event Type
    Malfunction
    Date Received
    August 8, 2025
    Date of Event
    July 31, 2025
    Report Date
    August 8, 2025
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152407319
    PMA / PMN Number
    K232380
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP INDICATED A DATA LOG CORRUPTION. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS IN 200-210 MG/DL RANGE. REPORTEDLY, CUSTOMER CONTINUED USING PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2162118 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ+ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE 1000354 00389152407319

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female