BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 2822397 · Received November 7, 2012

    Report

    Report Number
    3004753838-2012-00301
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 14, 2012
    Report Date
    October 14, 2012
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P050012
    Product Problem
    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)(6) 2012 TO REPORT THAT AFTER REMOVAL OF SENSOR ON THE SAME DAY, THE WIRE WAS MISSING FROM UNDERSIDE OF SENSOR POD. THE PATIENT REMOVED THE SENSOR POD FROM HIS BODY WITHOUT THE TRANSMITTER ATTACHED, WHICH IS A PRACTICE AGAINST CGM'S USER'S GUIDE RECOMMENDATIONS. NO PORTION OF THE WIRE IS VISIBLE AT THE INSERTION SITE. AT THE TIME OF HIS CALL TO TECHNICAL SUPPORT, PATIENT REPORTS NO PAIN, NO MEDICAL INTERVENTION, AND THAT HE IS IN FINE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-03 5039461

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other