BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3001049 · Received March 13, 2013

    Report

    Report Number
    3004753838-2013-00062
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 9, 2013
    Report Date
    February 13, 2013
    Manufacturer
    DEXCOM INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(4) 2013 TO REPORT THAT ON (B)(6) 2013, WHILE AT WORK, HE WAS SPEAKING TO HIS DAUGHTER ON THE PHONE WHEN HE SUFFERED A HYPOGLYCEMIC EPISODE AND BECAME INCOHERENT. HIS DAUGHTER ASKED HIM TO GIVE THE PHONE TO A PASSERBY WHO ENDED UP CALLING PARAMEDICS. PATIENT BELIEVES HE FELL, SCRAPED HIS KNEE AND ELBOW BUT ONLY REMEMBERS BEING AWAKENED BY THE AMBULANCE. PATIENT WAS TREATED ON SITE WITH GLUCOSE SHOTS AND AN IV. PATIENT STATES THAT CGM ALERTED HIM OF READINGS UNDER 55 MG/DL, WHILE HIS BG, MEASURED WITH A GLUCOSE METER, WAS 29 MG/DL BUT PATIENT BELIEVED HE HAD A LONGER WINDOW TO SELF-TREAT BEFORE BEING INCAPACITATED BY HIS HYPOGLYCEMIA. PATIENT HAS AGREED TO SEND HIS CGM DATA FOR DEXCOM TO INVESTIGATE CGM VALUES AROUND THE TIME OF THE HYPOGLYCEMIC EVENT. AT THE TIME OF HIS CALL TO DEXCOM TECHNICAL SUPPORT, PATIENT WAS FEELING BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105639 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM INC. 9500-27

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other