BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4090846 · Received September 15, 2014

    Report

    Report Number
    3004753838-2014-30071
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 9, 2014
    Report Date
    August 20, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEXCOM REVIEWED RECEIVER DATA ON (B)(4) 2014. DATA COULD NOT CONFIRM INACCURATE READINGS FROM CGM.

    Description of Event or Problem · 1

    FOREIGN DISTRIBUTOR CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO REPORT CGM INACCURACY COMPARED TO BLOOD GLUCOSE METER ON (B)(6) 2014. PATIENT INSERTED SENSOR IN BUTTOCKS WHICH IS NOT AN APPROVED SITE. PATIENT DID NOT REPORT ANY INJURY OR MEDICAL INTERVENTION AT THE TIME OF CONTACT WITH DEXCOM TECHNICAL SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568695 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-35 5157414

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR