BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 23236370 · Received October 7, 2025

    Report

    Report Number
    3013756811-2025-231649
    Event Type
    Injury
    Date Received
    October 7, 2025
    Date of Event
    August 7, 2025
    Report Date
    October 7, 2025
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    PMA / PMN Number
    K203234
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    VOLUNTARY MEDWATCH RECEIVED REPORTED: MY DEXCOM G7 HAD A "BRIEF SENSOR ISSUE" THAT LASTED SEVERAL HOURS. MY TANDEM INSULIN PUMP WAS GETTING FALSE READINGS THAT LEAD TO INSULIN STACKING, WHICH CAUSE MY BLOOD SUGAR TO CRASH SEVERELY AND I ALMOST PASSED OUT. I HAD TO CLOCK OUT OF MY REMOTE JOB EARLY AND GET A NOTE FROM MY ENDOCRINOLOGIST TO EXCUSE MY LEAVING EARLY. PATIENT CODES: (B)(6). DEVICE CODES: 1535, 3023, 2339. REFERENCE REPORT # MW5175116. ADDITIONAL INFORMATION RECEIVED FOR MW5175117 ON (B)(6) 2025 TO UPDATE PROCODE TO QFG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2699949 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE 1002717

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Other