BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 22351814 · Received June 27, 2025

    Report

    Report Number
    3004753838-2025-165991
    Event Type
    Injury
    Date Received
    June 27, 2025
    Date of Event
    January 28, 2025
    Report Date
    June 27, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270004109
    PMA / PMN Number
    K213919
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) DIABETES MELLITUS IS A KNOWN CAUSE OF HYPERGLYCEMIA. H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ADVERSE EVENT OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ACCORDING TO THE PATIENT¿S PARENT, ON APPROXIMATELY (B)(6) 2025, THE PATIENT FELT DIZZY AND COULD NOT WALK. THE CGM DIDN¿T PROVIDE ANY READINGS. THERE WAS ONLY A SYMBOL, BUT THE PARENT COULDN¿T RECALL WHAT IT LOOKED LIKE AND IF THERE WAS AN ALERT MESSAGE. THE PARENT DROVE THE PATIENT TO AN URGENT CARE CENTER. UPON ARRIVAL, DOCTOR TOOK A BG READING WHICH WAS 499 MG/DL. THE DOCTOR ADVISED THEM TO GO TO CEDARS SINAI MEDICAL CENTER. AT AROUND 3:00 PM, THEY ARRIVED AT CEDARS SINAI MEDICAL CENTER EMERGENCY ROOM (ER). ER PERSONNEL TOOK ANOTHER BG TEST WITH A RESULT OF 495 MG/DL. THE PATIENT WAS TREATED WITH INTRAVENOUS MEDICATION AND INSULIN. THE PATIENT WAS DISCHARGED AROUND 6:30 PM AFTER SOME OBSERVATION. AT THE TIME OF THE REPORT THE PATIENT WAS OKAY. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    973487 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NI NI 00386270004109

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Other