BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4130233 · Received September 30, 2014

    Report

    Report Number
    3004753838-2014-27601
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    January 4, 2014
    Report Date
    January 4, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING COMPLAINT CLOSURE REVIEW, IT WAS DETERMINED THAT THIS COMPLAINT IS A REPORTABLE EVENT. EVALUATION OF THE RETURNED RECEIVER CONFIRMED A HARDWARE ERROR CODE. THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE COMPONENT IN THE RECEIVER'S PRINTED CIRCUIT BOARD.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO REPORT A HARDWARE FAILURE THE PATIENT EXPERIENCED ON (B)(6) 2014. 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
    607612 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT20649

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR