BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4241388 · Received November 10, 2014

    Report

    Report Number
    3004753838-2014-25817
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    September 25, 2014
    Report Date
    October 14, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND FOUND NO DEFECTS. RECEIVER DATA LOG WAS DOWNLOADED AND NO ERRORS WERE OBSERVED. DEVICE FAILED FUNCTIONAL TESTING. FURTHER TESTS SHOWED THAT THE SPEAKER IS DEFECTIVE. THE ROOT CAUSE WAS DETERMINED TO BE AN ASSEMBLY ERROR. A CAPA HAS BEEN INITIATED FOR THIS ISSUE.

    Description of Event or Problem · 1

    PATIENT'S WIFE CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO CLAIM INTERMITTENT AUDIO OUTPUT ON (B)(6) 2014, RESULTING IN PATIENT EXPERIENCING A LOW. PATIENT'S WIFE REPORTED COMING HOME AND FINDING PATIENT BARELY CONSCIOUS, BUT ON THE FLOOR. REPORTED RECEIVER WAS NOT ALERTING, BUT FS WAS 28. PATIENT'S WIFE THINKS PARAMEDICS GAVE PATIENT A GLUCAGON SHOT TO THE THIGH. PEANUT BUTTER, ORANGE/PINEAPPLE JUICE AND IV SUGAR WATER WERE ALSO PROVIDED. PATIENT AND WIFE DECLINED PATIENT BEING TAKEN TO THE HOSPITAL. SINCE PATIENT IS ALREADY IN HOSPICE CARE FOR COPD, ELECTED TO HAVE THE HOSPICE NURSE COME OVER AND TAKE CARE OF PATIENT. NO INJURIES OR FURTHER MEDICAL INTERVENTION WAS REPORTED. ADDITIONALLY, DURING THE CALL, DEXCOM TECHNICAL SUPPORT ADVISED PATIENT'S WIFE TO TEST THE ALERT FUNCTIONALITY AND REPORTED ALERTS WERE FUNCTIONAL. CURRENT CONDITION OF PATIENT WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722611 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT20649

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening| O