BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 24309725 · Received February 10, 2026

    Report

    Report Number
    3004753838-2026-088373
    Event Type
    Malfunction
    Date Received
    February 10, 2026
    Date of Event
    January 28, 2026
    Report Date
    March 3, 2026
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270004109
    PMA / PMN Number
    K213919
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    (B)(4). PLEASE DISREGARD INITIAL REPORTING OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NOT REPORTABLE.

    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 ARM ON (B)(6)2026. ON (B)(6)2026, THE PATIENT REPORTED NO SYMPTOMS ON THE DAY OF THE EVENT. THE PATIENT WAS BROUGHT TO THE HOSPITAL, WHERE THEY WERE TREATED WITH INTRAVENOUS GLUCOSE. AT AN UNSPECIFIED TIME, A COMPARISON WAS PERFORMED BETWEEN THE CGM AND A BLOOD GLUCOSE METER: THE CGM DISPLAYED A VALUE OF 80 MG/DL, WHILE THE FINGERSTICK BLOOD GLUCOSE READING WAS 134 MG/DL. NO ADDITIONAL TREATMENT OR MEDICATION WAS REPORTED, AND THE PATIENT WAS DISCHARGED THE SAME DAY. THERE WAS NO DOCUMENTATION OF FURTHER MEDICAL EVALUATION OR INTERVENTION. AT THE TIME OF THE REPORT, THE PATIENT WAS DESCRIBED AS STABLE. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE B 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, IT WAS DETERMINED THAT A REPORT WAS SUBMITTED IN ERROR, A CORRECTION WAS UPDATED ON 02/19/20265. IT WAS CLARIFIED THAT ON (B)(6) 2026, THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS PRIOR TO SEEKING MEDICAL CARE. UPON ARRIVAL AT THE HOSPITAL, A FINGERSTICK BG MEASUREMENT WAS PERFORMED BEFORE ANY TREATMENT WAS ADMINISTERED, AND THE BG READING WAS 134 MG/DL. ALTHOUGH THE PATIENT RECEIVED INTRAVENOUS TREATMENT, THE BG VALUE OBTAINED PRIOR TO INTERVENTION INDICATED THAT THE PATIENT WAS NOT IN A CRITICAL STATE OF HYPOGLYCEMIA OR HYPERGLYCEMIA. THEREFORE, THE INTRAVENOUS THERAPY WAS UNLIKELY TO HAVE BEEN RELATED TO DIABETES MANAGEMENT AND WAS MOST LIKELY ADMINISTERED AS PART OF STANDARD OBSERVATION OR GENERAL MEDICAL EVALUATION. UPON FURTHER REVIEW, IT WAS DETERMINED THAT THE PATIENT ALLEGATION DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371126 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9500-161 1825328002 00386270004109

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Other