BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3633141 · Received February 18, 2014

    Report

    Report Number
    3004753838-2014-01367
    Event Type
    Malfunction
    Date Received
    February 18, 2014
    Date of Event
    January 18, 2014
    Report Date
    January 18, 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 REPORTED PERMANENT LOSS OF "Y".

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO REPORT THAT THE RECEIVER DISPLAYED INTERMITTENT OUT OF RANGE SIGNALS FOR AROUND 4 AND A HALF HOURS ON (B)(6) 2014. PATIENT DID NOT REPORT ANY INJURY OR MEDICAL INTERVENTION AT THE TIME OF CONTACT WITH DEXCOM TECHNICAL SUPPORT. DEXCOM HAS ISSUED AN RGA FOR PATIENT TO RETURN THE DEVICE TO BE INVESTIGATED.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO REPORT THAT THE RECEIVER DISPLAYED PERMANENT LOSS OF "Y" OUT OF RANGE SIGNALS FOR AROUND 4 AND A HALF HOURS ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103264 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS, PRODUCT CODE:MDS MDS DEXCOM INC. MT20649 5047833

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other