BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4130602 · Received September 30, 2014

    Report

    Report Number
    3004753838-2014-30485
    Event Type
    Injury
    Date Received
    September 30, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO REPORT HYPOGLYCEMIC EVENT AND CGM INACCURACY COMPARED TO BLOOD GLUCOSE METER ON (B)(6) 2014. PATIENT COLLAPSED AND PATIENT'S BOSS ADMINISTERED JUICE AND GLUCOSE TABLETS TO PATIENT. PARAMEDICS ARRIVED, HOWEVER PATIENT WAS NOT ADMITTED TO THE HOSPITAL. PATIENT DID NOT CALIBRATE ACCORDING TO USER GUIDE RECOMMENDATIONS. AT THE TIME OF CONTACT WITH DEXCOM TECHNICAL SUPPORT, NO FURTHER MEDICAL INTERVENTION OR INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609321 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other