BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM

    MDR report key: 5671758 · Received May 23, 2016

    Report

    Report Number
    3004753838-2016-37948
    Event Type
    Malfunction
    Date Received
    May 23, 2016
    Date of Event
    April 19, 2016
    Report Date
    April 22, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    30386270000164
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM ON (B)(6) 2016 TO REPORT CONTINUOUS GLUCOSE MONITORING (CGM) INACCURACIES COMPARED TO BLOOD GLUCOSE (BG) METER THAT OCCURRED ON (B)(6) 2016. THE SENSOR WAS INSERTED ON (B)(6) 2016. AT THE TIME OF CONTACT, NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION. THE DATA LOG WAS NOT RECEIVED FOR INVESTIGATION. THE REPORTED EVENT OF INACCURATE BLOOD GLUCOSE VALUES CANNOT BE CONFIRMED. HOWEVER, THE RECEIVER ((B)(4)) THAT WAS USED WITH THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION ON 05/20/2016. THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP WILL BE SUBMITTED UPON COMPLETION.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MDR, THE COMPLAINT SENSOR WAS NOT RETURNED TO DEXCOM. THE RECEIVER (PART NUMBER STR-DR-PNK SERIAL NUMBER (B)(4)/LOT NUMBER 5201405) WAS RETURNED ON 05/20/2016. THE RETURNED RECEIVER WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THERE WAS NO FAILURE DETECTED RELATED TO THE COMPLAINT. THE RECEIVER LOG WAS DOWNLOADED AND NO ERRORS WERE FOUND RELATING TO THE COMPLAINT. A ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329606 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM MDS MDS DEXCOM, INC. MT22495 5201405 30386270000164

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR