BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4232847 · Received November 6, 2014

    Report

    Report Number
    3004753838-2014-32528
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 9, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT'S MOTHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO REPORT CGM INACCURACY COMPARED TO BLOOD GLUCOSE METER ON (B)(6) 2014. PATIENT WENT TO SCHOOL NURSE WHILE IN CLASS SINCE HE WAS NOT FEELING GOOD AND WAS INCOHERENT. SCHOOL NURSE ADMINISTERED GLUCOSE TABLETS AND WATER. PATIENT'S MOTHER GIVE PATIENT PROTEIN. PATIENT'S MOTHER DID NOT REPORT ANY MEDICAL INTERVENTION AND THE TIME OF CONTACT WITH DEXCOM TECHNICAL SUPPORT, PATIENT WAS IN FINE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712715 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention