BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3873153 · Received June 13, 2014

    Report

    Report Number
    3004753838-2014-05675
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 17, 2014
    Report Date
    May 17, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    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 CLAIMED THAT ON (B)(6) 2014, UPON SENSOR APPLICATOR REMOVAL, SENSOR WIRE REMAINED LEFT BEHIND AT INSERTION SITE. PATIENT'S MOTHER INSERTED SENSOR IN ARM WHICH IS NOT AN APPROVED SITE. PATIENT'S MOTHER CLAIMED SOME BLEEDING AT THE INSERTION SITE. PATIENT'S MOTHER DID NOT REPORT ANY FURTHER INJURY OR MEDICAL INTERVENTION AT TIME OF CONTACT WITH DEXCOM TECHNICAL SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350706 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 5134440

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Other