BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 17027674 · Received May 30, 2023

    Report

    Report Number
    3004753838-2023-106886
    Event Type
    Injury
    Date Received
    May 30, 2023
    Date of Event
    April 5, 2023
    Report Date
    May 30, 2023
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    80386270000251
    PMA / PMN Number
    DEN170088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF DIABETIC KETOACIDOSIS. HEALTH EFFECT - CLINICAL CODE - MYOCARDIAL INFARCTION - 1969 - E061202. HEALTH EFFECT - CLINICAL CODE - ISCHEMIC HEART DISEASE - E0612.

    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 (B)(6) 2023, THE PATIENT¿S CGM DISPLAYED LOW AND HE SELF-TREATED WITH FOOD AND JUICE; HOWEVER, THE CGM CONTINUED TO DISPLAY LOW. THE PATIENT BECAME ¿OUT OF IT¿ AND HIS SPOUSE CALLED EMERGENCY MEDICAL SERVICES. EMS TRANSPORTED THE PATIENT TO THE HOSPITAL WHERE A BG WAS PERFORMED WHICH WAS 1300 MG/DL. THE PATIENT WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS (DKA) AND A MYOCARDIAL INFARCTION (MI) WHICH WAS ASSOCIATED WITH HIS BG OF 1300 MG/DL. HE WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU), TREATED WITH IV INSULIN (NOVOLOG) AND FIVE OTHER UNSPECIFIED IV MEDICATIONS. AFTER 5 DAYS IN THE ICU, HIS BG RETURNED TO NORMAL AND HE WAS TRANSFERRED TO A STEP-DOWN UNIT. AFTER A TOTAL OF 7 DAYS, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. AT THE TIME OF THE REPORT, THE PATIENT RECOVERED, WAS HOME AND REPORTED THAT THEY GET TIRED EASILY. 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. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1829870 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. STS-OM-001 NI 80386270000251

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Other| H