BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3900779 · Received June 27, 2014

    Report

    Report Number
    3004753838-2014-05728
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO REPORT THAT ON (B)(6) 2014, UPON SENSOR POD REMOVAL, SENSOR WIRE BECAME DETACHED FROM SENSOR POD. PATIENT STATED THEY EXPERIENCED SOME BLEEDING DURING INSERTION AND REMOVED SENSOR POD. UPON REMOVAL OF SENSOR POD, PATIENT CLAIMED SENSOR WIRE REMAINED LEFT BEHIND AT SITE OF INSERTION. PATIENT STATED THEY REMOVED SENSOR WIRE WITHOUT ANY ISSUES AND DID NOT REPORT ANY FURTHER PAIN OR DISCOMFORT. PATIENT DID NOT REPORT ANY INJURY OR MEDICAL INTERVENTION AT TIME OF CONTACT WITH DEXCOM TECHNICAL SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377226 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 5134440

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other