BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITOR

    MDR report key: 6613405 · Received June 5, 2017

    Report

    Report Number
    3004753838-2017-49188
    Event Type
    Malfunction
    Date Received
    June 5, 2017
    Date of Event
    May 11, 2017
    Report Date
    May 11, 2017
    Manufacturer
    DEXCOM, INC.
    Product Code
    PFQ
    UDI-DI
    10386270000221
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(6) 2017 THAT ON (B)(6) 2017, THERE WAS AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2017. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. DATA WAS PROVIDED FOR EVALUATION. DATA REVIEW CONFIRMED THE REPORTED EVENT OF INACCURATE CGM VALUES. A ROOT CAUSE COULD NOT BE DETERMINED VIA DATA.

    Description of Event or Problem · 1

    THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THERE WAS NO FAILURE DETECTED RELATED TO THE COMPLAINT. A PAIRING TEST WAS PERFORMED WITH NORDIC BLUETOOTH DEVICE AND PASS. THE RECEIVER LOG WAS DOWNLOADED AND, UPON REVIEW, CONFIRMED THE REPORTED EVENT OF INACCURACIES. A ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393935 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITOR CONTINUOUS GLUCOSE MONITOR PFQ DEXCOM, INC. 9500-27 5214627 10386270000221

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR