BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3646173 · Received February 25, 2014

    Report

    Report Number
    3004753838-2014-03350
    Event Type
    Malfunction
    Date Received
    February 25, 2014
    Date of Event
    January 26, 2014
    Report Date
    January 26, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURNED COMPLAINT DEVICE WAS VISUALLY INSPECTED AND NO DEFECTS WERE FOUND. A REVIEW OF THE RECEIVER DATA LOG CONFIRMED A HARDWARE ERROR CODE. THE ROOT CAUSE WAS DETERMINED TO BE A HARDWARE COMPONENT FAILURE.

    Additional Manufacturer Narrative · 1

    (B)(4). A SECOND FOLLOW-UP IS BEING SUBMITTED FOR THIS SR-3945042 AS THE FIRST FOLLOW-UP WAS SUBMITTED INCORRECTLY AND THAT THE INFORMATION CONTAINED IN IT BELONGS TO MDR 3004753838-2014-03359. ALL INFORMATION REPORTED IN THE INITIAL REPORT FOR 3004753838-2014-03350 IS CURRENT. IF ADDITIONAL INFORMATION IS PROVIDED OR IF THE PRODUCT RETURNS FOR EVALUATION A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 AND CLAIMED THAT ON (B)(6) 2014 PATIENT EXPERIENCED HARDWARE FAILURE. PATIENT WAS ADVISED TO RESTART DEVICE ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115851 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT20649 5076241

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other