BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3831088 · Received May 23, 2014

    Report

    Report Number
    3004753838-2014-05621
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 29, 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 TO REPORT THAT SHE WAS UNABLE TO LOCATE THE SENSOR WIRE UPON REMOVAL ON (B)(6) 2014. PATIENT'S MOTHER DID NOT REPORT ANY DISCOMFORT AT INSERTION SITE. AT THE TIME OF THE CALL TO DEXCOM TECHNICAL SUPPORT, NO MEDICAL INTERVENTION OR INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308569 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS, PRODUCT CODE: MDS MDS DEXCOM, INC. 9500-27 5131457

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other