BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4061449 · Received September 4, 2014

    Report

    Report Number
    3004753838-2014-28346
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    August 10, 2014
    Report Date
    August 11, 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). DEXCOM REVIEWED RECEIVER DATA ON (B)(6) 2014. THERE WERE INDICATIONS OF GAPS IN TRANSMISSION.

    Additional Manufacturer Narrative · 1

    (B)(4). SUBSEQUENT TO THE INITIAL MDR (B)(4), USED WITH THE COMPLAINT TRANSMITTER DEVICE, WAS RETURNED ON (B)(4) 2014. THE RETURNED COMPLAINT RECEIVER WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. EVALUATION OF THE RETURNED RECEIVER AND REVIEW OF THE DOWNLOADED DATA LOG CONFIRMED THE REPORTED EVENT OF INTERMITTENT ANTENNA ICON.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542094 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9438-01

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR