BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3791380 · Received May 5, 2014

    Report

    Report Number
    3004753838-2014-06932
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 9, 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). EVALUATION OF THE RETURNED DEVICE CONFIRMED THE PERMANENT OUT OF RANGE SIGNAL.

    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.DEXCOM HAS ISSUED AN RGA FOR PATIENT TO RETURN THE DEVICE TO BE INVESTIGATED.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
    267649 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM INC 9438-01 5134479

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other