BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 21962359 · Received May 5, 2025

    Report

    Report Number
    3004753838-2025-107284
    Event Type
    Malfunction
    Date Received
    May 5, 2025
    Date of Event
    April 21, 2025
    Report Date
    May 6, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    DEN170088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA. H6: HEALTH EFFECT CLINICAL CODE - AMBULATION DIFFICULTIES.

    Additional Manufacturer Narrative · 0

    (B)(4). B1 ADVERSE EVENT AND/OR PRODUCT PROBLEM - CORRECTION- REMOVED "ADVERSE EVENT". B2 OUTCOMES ATTRIBUTED TO ADVERSE EVENT - CORRECTION - REMOVED "OTHER". B5 DESCRIBE EVENT OR PROBLEM - CORRECTION. H1 TYPE OF REPORTABLE EVENT - CORRECTION. H2 CORRECTION. H6 HEALTH EFFECT IMPACT CODE - CORRECTION. H6 HEALTH EFFECT CLINICAL CODE - CORRECTION. H10 CORRECTION- REMOVED "DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA" AND "H6: HEALTH EFFECT CLINICAL CODE - AMBULATION DIFFICULTIES".

    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 THIGH ON (B)(6)2025, WHICH IS OFF-LABEL USAGE OF THE DEVICE. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT EXPERIENCED INACCURATE CGM VALUES. THE MOBILE DEVICE SHOWED CGM 300 MG/DL AND THE PATIENT TOOK INSULIN SHOTS. HE COULDN'T TALK OR WALK WELL AND WAS DIZZY. THE BG WAS 40 MG/DL. THE PATIENT TOOK SUGAR TABLETS. DOCUMENTATION STATES HE WAS IN THE HOSPITAL FROM (B)(6) 2025. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE D ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIAL MDR, A CORRECTION IS REQUIRED. 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 THIGH ON (B)(6) 2025, WHICH IS OFF-LABEL USAGE OF THE DEVICE. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE E ZONE OF THE PARKES ERROR GRID. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458481 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Other