BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3790959 · Received May 5, 2014

    Report

    Report Number
    3004753838-2014-05549
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    August 16, 2013
    Report Date
    August 19, 2013
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL ON (B)(6) 2013 AND CLAIMED THAT ON (B)(6) 2013 PATIENT HAD TO REMOVE SENSOR PRIOR TO SENSOR EXPIRATION PERIOD. PATIENT CLAIMED THAT SHE VISITED THE EMERGENCY ROOM DUE TO AN ALLERGIC REACTION TO DEXATRAM ADMINISTERED FOR AN UNRELATED SINUS INFECTION. WHILE AT THE EMERGENCY ROOM ON (B)(6) 2014 PATIENT RECEIVED A SHOT OF BENADRYL. NO FURTHER MEDICAL INTERVENTION WAS NECESSARY. AT THE TIME OF THE CALL, PATIENT REPORTED ITCHING AND REDNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267578 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS, PRODUCT CODE: MDS MDS DEXCOM, INC. 9500-27 5067250

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other