BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4541802 · Received February 24, 2015

    Report

    Report Number
    3004753838-2015-11508
    Event Type
    Malfunction
    Date Received
    February 24, 2015
    Date of Event
    January 30, 2015
    Report Date
    January 30, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION; HOWEVER, THE DATA LOG WAS PROVIDED BY THE PATIENT. IT WAS DOWNLOADED AND REVIEWED ON (B)(6) 2015 CONFIRMING THE REPORTED EVENT OF INACCURATE READINGS.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015, TO REPORT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM AND THE BLOOD GLUCOSE (BG) METER ON (B)96) 2015. THE PATIENT DID NOT REPORT INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127649 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 5194465

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR