BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3082791 · Received April 29, 2013

    Report

    Report Number
    3004753838-2013-00116
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    March 23, 2013
    Report Date
    March 30, 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'S DAUGHTER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2013 TO REPORT THAT ON (B)(6) 2013 PATIENT HAD EXPERIENCED A HYPOGLYCEMIC EVENT. PATIENT'S DAUGHTER FOUND PATIENT PASSED OUT AND CALLED THE PARAMEDICS. THE PARAMEDICS ARRIVED AND TOOK PATIENT TO THE HOSPITAL. PATIENT WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2013. PATIENT HAD TAKEN ACETAMINOPHEN, WHICH IS A CGM CONTRAINDICATED PRODUCT. AT THE TIME OF HER CALL TO DEXCOM TECHNICAL SUPPORT, PATIENT'S DAUGHTER REPORTS THAT PATIENT IS IN FINE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184935 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| O