BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 7142794 · Received December 22, 2017

    Report

    Report Number
    3004753838-2017-116738
    Event Type
    Malfunction
    Date Received
    December 22, 2017
    Date of Event
    October 28, 2017
    Report Date
    November 27, 2017
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PLEASE DISREGARD ALL INFORMATION THAT WAS REPORTED IN THE INITIAL MDR AND FOLLOW-UP REPORTS FOR REPORT NUMBER 3004753838-2017-116738 AS THIS IS A DUPLICATE REPORT. THIS CUSTOMER COMPLAINT HAS BEEN PREVIOUSLY REPORTED IN REPORT NUMBER 3004753838-2017-112412.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DESCRIBE EVENT OR PROBLEM - CORRECTION: " THE RECEIVER WAS OPENED AND THE UI PCBA WAS DETACHED TO PERFORM A DOWNLOAD, A REVIEW CONFIRMED ERROR WITHIN THE INVESTIGATION WINDOW. THE REPORTED EVENT OF RECEIVER CEASED TO FUNCTION WAS CONFIRMED DURING LOG REVIEW."

    Description of Event or Problem · 1

    THE COMPLAINT RECEIVER DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. THE RECEIVER WAS CHARGED AND WAS PERPETUALLY REBOOTING. THE RECEIVER WAS OPENED AND THE UI PCBA WAS DETACHED TO PERFORM A DOWNLOAD, A REVIEW CONFIRMED ERROR WITHIN THE INVESTIGATION WINDOW. THE REPORTED EVENT OF RECEIVER CEASED TO FUNCTION WAS CONFIRMED DURING LOG REVIEW. A ROOT CAUSE COULD NOT BE DETERMINED POST INVESTIGATION.

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(4) 2017 THAT ON (B)(6) 2017 THE RECEIVER CEASED TO FUNCTION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT WAS PROVIDED FOR EVALUATION. THE COMPLAINT CONFIRMATION OF THE RECEIVER CEASED TO FUNCTION COULD NOT BE DETERMINED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE RECEIVER WAS OPENED AND THE UI PCBA WAS DETACHED TO PERFORM A DOWNLOAD, A REVIEW SHOWS PERPETUAL REBOOTING AND USER SHUTDOWN OBSEVED. THE REPORTED EVENT OF RECEIVER CEASED TO FUNCTION WAS NOT CONFIRMED DURING LOG REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922930 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. MT22719-1 5223238

    Patients

    Seq Age Sex Outcome Treatment
    1