BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G4 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3061177 · Received April 16, 2013

    Report

    Report Number
    3004753838-2013-00099
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 20, 2013
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INTERNATIONAL DISTRIBUTOR CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2013 TO REPORT THAT ON (B)(6) 2013 A PATIENT EXPERIENCED A HYPOGLYCEMIC EVENT. THE PATIENT WAS TAKEN TO THE HOSPITAL FOR TREATMENT OF HYPOGLYCEMIA. AT THE TIME OF THE INCIDENT PATIENT REPORTS THAT HIS CGM WAS IN GLUCOSE READING ERROR MODE. AT THE TIME OF HIS CONTACT WITH THE INTERNATIONAL DISTRIBUTOR, PATIENT REPORTED BEING IN FINE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163830 G4 CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-25 5052597

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization| O