BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 2760554 · Received September 26, 2012

    Report

    Report Number
    3004753838-2012-00266
    Event Type
    Injury
    Date Received
    September 26, 2012
    Date of Event
    August 8, 2012
    Report Date
    August 28, 2012
    Manufacturer
    DEXCOM INC.
    Product Code
    MDS
    PMA / PMN Number
    P050012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT'S WIFE CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2012 TO REPORT THAT DURING THE USE OF ONE SENSOR (INSERTED ON ESTIMATED DATE OF (B)(6) 2012) AND WITHIN ONE WEEK, PATIENT HAD SUFFERED TWO HYPOGLYCEMIC EVENTS WHILE ON A CONCOMITANT USE OF CGM AND ACETAMINOPHEN. ACETAMINOPHEN IS CONTRAINDICATED PER CGM'S USER'S GUIDE. PATIENT WAS NOT AWARE OF THE ACETAMINOPHEN CONTRAINDICATION WHILE USING CGM AND SUFFERED CONVULSIONS DURING HIS HYPOGLYCEMIC EPISODE. PATIENT'S WIFE CALLED PARAMEDICS. PARAMEDICS TREATED PATIENT WITH IV. DURING HER CALL TO DEXCOM TECHNICAL SUPPORT ON (B)(6) 2012, PATIENT'S WIFE REPORTED THAT PATIENT WAS FEELING BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM INC. 9500-03 5039781

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other