BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 22742653 · Received August 7, 2025

    Report

    Report Number
    3004753838-2025-214580
    Event Type
    Malfunction
    Date Received
    August 7, 2025
    Date of Event
    October 23, 2024
    Report Date
    October 1, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270003089
    PMA / PMN Number
    DEN170088
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G3 DATE RECEIVED BY MFG - CORRECTION TO THE DATE IN THE INITIAL MDR. THE CORRECT DATE IS 04/09/2025.

    Additional Manufacturer Narrative · 0

    (B)(4). PLEASE DISREGARD INITIAL REPORTING OF THIS EVENT AS THIS EVENT HAS NOW BEEN CONFIRMED TO BE A DUPLICATE OF 3004753838-2025-093751.

    Additional Manufacturer Narrative · 0

    (B)(4), DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIAL MDR, A CORRECTION IS REQUIRED.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIAL MDR, IT WAS DETERMINED THAT A REPORT WAS SUBMITTED IN ERROR. UPON FURTHER REVIEW, IT WAS DETERMINED THAT THIS REPORT WAS CONFIRMED TO BE A DUPLICATE OF 3004753838-2025-093751. THE DATE DISCREPANCY HAS BEEN REPORTED TO BE CORRECTED TO THE EVENT DATE OF 09/21/2024.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. ON APPROXIMATELY (B)(6) 2024, THE CGM READING WAS HIGH AND THE PATIENT´S INSULIN PUMP AUTOMATICALLY DISPENSED INSULIN BASED ON THIS. THE PUMP GAVE THE PATIENT AN OPTION FOR ADMINISTERING EXTRA INSULIN, WHICH THE PATIENT DID. FIVE MINUTES AFTER THIS EXTRA BOLUS THE CGM READING WAS 8.0 MMOL/L. THE PATIENT EXPERIENCED A HYPOGLYCEMIC EVENT AND A SEIZURE. THE REPORTER STATED THAT THE INSULIN PUMP WAS NOT AT FAULT. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. PROBLEM COULD NOT BE CONFIRMED AND PROBABLE CAUSE CANNOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411211 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NI 00386270003089

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Other