BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3791435 · Received May 5, 2014

    Report

    Report Number
    3004753838-2014-07814
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 7, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT CONTACTED A DEXCOM PATIENT CARE SPECIALIST ON (B)(6) 2014 AND THE PATIENT CARE SPECIALIST THEN EMAILED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO REPORT CGM INACCURACY COMPARED TO BLOOD GLUCOSE METER ON (B)(6) 2014, ON BEHALF OF THE PATIENT. AT THE TIME OF THE CALL TO DEXCOM TECHNICAL SUPPORT, PATIENT CARE SPECIALIST DID NOT REPORT ANY MEDICAL INTERVENTION OR INJURIES ON BEHALF OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267712 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other