BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 24164076 · Received January 23, 2026

    Report

    Report Number
    3004753838-2026-071080
    Event Type
    Injury
    Date Received
    January 23, 2026
    Date of Event
    January 1, 2026
    Report Date
    February 5, 2026
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    K213919
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    3004753838-2026-071080 WAS REPORTED IN ERROR. PLEASE DISREGARD INITIAL REPORTING OF THIS EVENT AS THESE EVENTS WERE DOCUMENTED IN (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF DIABETIC KETOACIDOSIS. THIS REPORT IS 3 OF 7 ALLEGATIONS OF INACCURATE CGM VALUES THAT HAD SIMILAR EVENT DETAILS. RELATED RECORDS: (B)(4).

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIAL MDR, IT WAS DETERMINED THAT A REPORT WAS SUBMITTED IN ERROR. UPON FURTHER REVIEW, THE EVENTS WERE DOCUMENTED IN (B)(4).

    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 WEARABLE WAS INSERTED INTO THE SKIN. ON 01/01/2026, IT WAS REPORTED THAT THE PATIENT REPORTED ON A SOCIAL MEDIA PLATFORM THAT CGM INACCURACIES CAUSED THEM TO EXPERIENCE DIABETIC KETOACIDOSIS ON 7 DIFFERENT OCCASIONS. THIS REPORT IS 3 OF 7 ALLEGATIONS OF INACCURATE CGM VALUES THAT HAD SIMILAR EVENT DETAILS. NO SPECIFIC READINGS WERE REPORTED FROM THESE EVENTS, BUT THE PATIENT STATED THAT FROM THE START "IT" RAN 2 TO 300 UNITS HIGHER THAN WHAT "IT" ACTUALLY WAS. IT IS UNCLEAR IF THE PATIENT WAS ALLEGING A HIGH BIAS OR A LOW BIAS INACCURACY FROM THE CGM DEVICE. NO FURTHER EVENT INFORMATION WAS AVAILABLE, AND THE PATIENT DECLINED TO PROVIDE FURTHER INFORMATION. AN EMAIL WAS SENT TO THE PATIENT BY CCA ON 01/21/2026 TO OBTAIN FURTHER INFORMATION, BUT NO RESPONSE WAS RECEIVED. NO OTHER DETAILS WERE DOCUMENTED. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THERE WERE NO REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222051 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Other