BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3891091 · Received June 24, 2014

    Report

    Report Number
    3004753838-2014-22956
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 2, 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). COMPLAINT DEVICE WAS RETURNED TO DEXCOM AND EVALUATED. THE REPORTED FAILURE WAS NOT CONFIRMED AND NO FAILURE DETECTED.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO REPORT AN OUT OF RANGE SIGNAL ON (B)(6) 2014. PATIENT DID NOT REPORT ANY INJURY OR MEDICAL INTERVENTION AT THE TIME OF CONTACT WITH DEXCOM TECHNICAL SUPPORT. DEXCOM ISSUED AN RGA FOR THE PATIENT TO RETURN THE DEVICE TO BE INVESTIGATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368314 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM INC MT20649 5134500

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other