BEUDAMED
    FDA Adverse Event Other Summary report: N

    TANDEM

    MDR report key: 23895884 · Received December 26, 2025

    Report

    Report Number
    MW5181195
    Event Type
    Other
    Date Received
    December 26, 2025
    Date of Event
    December 16, 2025
    Report Date
    December 18, 2025
    Manufacturer
    TANDEM DIABETES CARE, INC.
    Product Code
    QFG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I USE A TANDEM INSULIN PUMP WITH A DEXCOM G6 CONTINUOUS GLUCOSE MONITOR. SINCE THE LAST WEEK OF (B)(6), I HAVE SUFFERED 5 BLOOD SUGAR READING OF 350ML/DL. NO INSULIN LEAKED WAS NOTICED. I REPORTED THIS TO TANDEM HELP DESK TO GET REPLACEMENT INFUSION SETS. I WAS INFORMED THAT THE REPLACEMENT SETS WOULD BE SLIGHTLY DIFFERENT AS A MANUFACTURER WAS HAVING TROUBLE. I WAS TOLD I (ME) NEED TO CHECK THE SETS TO SEE IF THE INCURSION NEEDLE STUCK OUT PAST THE CANNULA. WHY DOESN'T YOUR QUALITY CONTROL QUALITY ASSURANCE TAKE CARE OF THAT? THAT'S A LOT TO CHECK. IF YOU KNOW, WHY DIDN'T YOU TELL ME? WE DIDN'T WANT PEOPLE TO BE ALARMED. SO, IT'S BETTER FOR ME TO HAVE HIGH BLOOD SUGARS AND NOT BE ALARMED. I'VE GOT MORE SO CALL ME (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2403853 TANDEM ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Disability| O DEXCOM G6.