BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G4 PLATINUM PEDIATRIC CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3870847 · Received June 12, 2014

    Report

    Report Number
    3004753838-2014-05678
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    April 29, 2014
    Report Date
    May 19, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    PATIENT'S MOTHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 AND STATED THAT ON (B)(6) 2014, PATIENT EXPERIENCED A HYPOGLYCEMIC EVENT AND PARAMEDICS WERE CONTACTED. UPON THE ARRIVAL OF THE PARAMEDICS, PATIENT WAS ADMINISTERED AN IV. NO FURTHER MEDICAL INTERVENTION WAS NECESSARY. AT THE TIME OF THE CALL WITH DEXCOM TECHNICAL SUPPORT, PATIENT'S MOTHER STATED THAT PATIENT WAS OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347133 G4 PLATINUM PEDIATRIC CONTINUOUS GLUCOSE MONITORING SYSTEM MDS, PRODUCT CODE: MDS MDS DEXCOM, INC. MT22430-BLU 5120294

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Other