BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4243271 · Received November 11, 2014

    Report

    Report Number
    3004753838-2014-25832
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 16, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND FOUND NO DEFECTS. RECEIVER DATA LOG WAS DOWNLOADED AND NO ERRORS WERE OBSERVED. DEVICE FAILED FUNCTIONAL TESTING. FURTHER TESTS SHOWED THAT THE SPEAKER IS DEFECTIVE. THE ROOT CAUSE WAS DETERMINED TO BE AN ASSEMBLY ERROR. A CAPA HAS BEEN INITIATED FOR THIS ISSUE.

    Description of Event or Problem · 1

    PATIENT'S MOTHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO CLAIM NO AUDIO OUTPUT PATIENT EXPERIENCED ON (B)(6) 2014. AT THE TIME OF THE CALL TO DEXCOM TECHNICAL SUPPORT, NO MEDICAL INTERVENTION OR INJURIES WERE REPORTED. ADDITIONALLY, DURING THE CALL, DEXCOM TECHNICAL SUPPORT ADVISED PATIENT'S MOTHER TO TEST THE ALERT FUNCTIONALITY AND REPORTED ALERTS WERE NOT FUNCTIONAL, BUT DEVICE DID VIBRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725840 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT20649

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR