BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3949858 · Received July 22, 2014

    Report

    Report Number
    3004753838-2014-25037
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 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). A FOLLOW-UP MDR WAS SUBMITTED FOR SR-061258 WITH THE MDR NUMBER 3004753838-2014-25037 WHICH IS FOR SR-052708. THE MDR NUMBER FOR SR-061258 IS 3004753838-2014-27037. A SECOND FOLLOW-UP IS BEING SUBMITTED FOR THIS SR-052708 INFORMING THE FDA THAT THE FIRST FOLLOW-UP WAS SUBMITTED INCORRECTLY AND THAT THE INFORMATION CONTAINED IN IT BELONGS TO MDR 3004753838-2014-27037. ALL INFORMATION REPORTED IN THE INITIAL REPORT FOR 3004753838-2014-052708 IS CURRENT. IF ADDITIONAL INFORMATION IS PROVIDED OR IF THE PRODUCT RETURNS FOR EVALUATION A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURNED COMPLAINT DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. 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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO CLAIM NO AUDIO OUTPUT 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 TO TEST THE ALERT FUNCTIONALITY AND REPORTED ALERTS WERE FUNCTIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428346 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT20649

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR