BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 22396775 · Received July 3, 2025

    Report

    Report Number
    3004753838-2025-172063
    Event Type
    Malfunction
    Date Received
    July 3, 2025
    Date of Event
    June 21, 2025
    Report Date
    July 24, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    40386270000253
    PMA / PMN Number
    DEN170088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). B1 ADVERSE EVENT AND/OR PRODUCT PROBLEM - CORRECTION. B2 OUTCOMES ATTRIBUTED TO ADVERSE EVENT - CORRECTION TO REMOVE OTHER SERIOUS FROM THE INITIAL MDR. B5 DESCRIBE EVENT OR PROBLEM - CORRECTION. H2 CORRECTION. H6 HEALTH EFFECT - IMPACT CODE - CORRECTION. H6 HEALTH EFFECT - CLINICAL CODE - CORRECTION.

    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, IT WAS DETERMINED THAT A SERIOUS ADVERSE EVENT REPORT WAS SUBMITTED IN ERROR. UPON FURTHER REVIEW, IT WAS DETERMINED THAT THE SERIOUS ADVERSE EVENT WAS NOT RELATED TO THIS ISSUE THAT OCCURRED ON (B)(6) 2025. THE SERIOUS ADVERSE EVENT WAS REPORTED UNDER MFR# 3004753838-2025-173402. HOWEVER, MFR# 3004753838-2025-172063 IS STILL A REPORTABLE EVENT BASED ON THE PEG BEING IN ZONE E. IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2025. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE C ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION FOUND A DIFFERENCE IN VALUES THAT FALL WITHIN THE E ZONE OF THE PARKES ERROR GRID. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    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. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT WAS ABOUT TO PASS OUT AND WAS INCOHERENT. THE PATIENT WAS TREATED BY THE HUSBAND WITH JUICE. AT AN UNSPECIFIED TIME OF THE EVENT THE CGM WAS READING 52 MG/DL AND THE BLOOD GLUCOSE READING WAS 250 MG/DL (NOT CONFIRMED IF THIS WAS AFTER THE TREATMENT). AT THE TIME OF THE REPORT THE PATIENT WAS STABLE. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE C ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION FOUND A DIFFERENCE IN VALUES THAT FALL WITHIN THE E ZONE OF THE PARKES ERROR GRID. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    939178 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NI 40386270000253

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Other