BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3453175 · Received November 6, 2013

    Report

    Report Number
    3004753838-2013-00350
    Event Type
    Malfunction
    Date Received
    November 6, 2013
    Date of Event
    October 9, 2013
    Report Date
    October 9, 2013
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEXCOM, INC. AND FDA AGREED DURING A FACILITY INSPECTION THAT ANY POSSIBLE BROKEN SENSOR WIRE WAS A REPORTABLE EVENT, EVEN IN THE ABSENCE OF ANY EVIDENCE OF PHYSICAL HARM OR NECESSITY FOR INTERVENTION.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(64 )2013 TO REPORT THAT ON (B)(6) 2013 DURING SENSOR DEPLOYMENT, SENSOR WIRE BROKE OFF IN THE APPLICATOR. PATIENT IS NOT EXPERIENCING ANY DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571963 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 5087171

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other