BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3024167 · Received March 27, 2013

    Report

    Report Number
    3004753838-2013-00078
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 2, 2013
    Report Date
    March 2, 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)(6) 2013 TO REPORT THAT ON (B)(6) 2013, PATIENT HAD SUFFERED A HYPOGLYCEMIC EPISODE. PATIENT'S WIFE CALLED PARAMEDICS AND PATIENT WAS TREATED WITH GLUCOSE VIA IV. ON (B)(6) 2013 DEXCOM'S CDE SAW PATIENT DURING A FOLLOW-UP VISIT. AT THE TIME OF HIS CALL TO DEXCOM TECHNICAL SUPPORT, PATIENT REPORTS THAT HE WAS FEELING FINE AND THAT CGM'S READINGS WERE ACCURATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126900 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM INC. 9500-27

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other