BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4252273 · Received November 14, 2014

    Report

    Report Number
    3004753838-2014-31837
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 20, 2014
    Report Date
    October 20, 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 NOT RETURNED FOR EVALUATION. HOWEVER, THE RECEIVER ((B)(4)) THAT WAS USED WITH THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION ON 11/05/2014. THE DEVICE WAS VISUALLY INSPECTED AND THE UNIVERSAL SERIAL BUS (USB) CONNECTOR WAS FOUND TO BE DISLODGED. FUNCTIONAL TESTING WAS NOT PREFORMED BECAUSE THE DEVICE WAS RECEIVED IN A CONDITION MAKING EVALUATION IMPOSSIBLE. THERE FOR THE COMPLAINT OF INTERMITTENT OUT OF RANGE COULD NOT BE CONFIRMED. 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 REPORT INTERMITTENT OUT OF RANGE SIGNAL ON (B)(6) 2014. AT THE TIME OF CONTACT THE PATIENT'S MOTHER DID NOT REPORT ANY INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737351 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9438-01

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR