BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3770847 · Received April 24, 2014

    Report

    Report Number
    3004753838-2014-05485
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 31, 2014
    Report Date
    March 31, 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).

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO REPORT THAT PATIENT EXPERIENCED A DETACHED SENSOR WIRE. PATIENT DID NOT KNOW THE DATE OF INSERTION OR THE DATE OF THE EVENT. PATIENT REPORTED DIFFICULTY WITH DEPLOYMENT. NO MEDICAL INTERVENTION WAS REQUIRED.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO REPORT THAT PATIENT EXPERIENCED A DETACHED SENSOR WIRE ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248444 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other