BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6201615 · Received December 22, 2016

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    Report

    Report Number
    3004753838-2016-81714
    Event Type
    Malfunction
    Date Received
    December 22, 2016
    Date of Event
    December 3, 2016
    Report Date
    December 3, 2016
    Manufacturer
    DEXCOM INC.
    Product Code
    MDS
    UDI-DI
    00386270000262
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(6) 2016, THAT ON (B)(6) 2016, THE RECEIVER DISPLAYED AN ERROR 121. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. THE RECEIVER WAS RETURNED FOR EVALUATION. EXTERNAL VISUAL INSPECTION FOUND NO OBSERVATIONS RELATED TO THE CUSTOMER COMPLAINT. THE RECEIVER DATA LOG WAS DOWNLOADED AND REVIEWED AND FIRMWARE ERRORS WERE OBSERVED. THE REPORTED EVENT OF THE RECEIVER DISPLAYING ERROR CODE FAILURES WAS CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847751 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM INC. MT22719-PNK 5213159 00386270000262

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR