BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 2880507 · Received December 19, 2012

    Report

    Report Number
    3004753838-2012-00341
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    November 23, 2012
    Report Date
    November 23, 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 CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2012 TO REPORT THAT AROUND 10:30 AM, SHE HAD SUFFERED A HYPOGLYCEMIC EPISODE WHILE ON A CONCOMITANT USE OF CGM AND ACETAMINOPHEN. ACETAMINOPHEN USE IS CONTRAINDICATED PER CGM'S USER'S GUIDE. PATIENT WAS OUT SHOPPING WHEN SHE LOST CONSCIOUSNESS AND ONLY WOKE UP TO PARAMEDICS TREATING HER. PATIENT WAS TREATED WITH GLUCOSE TABS. AT THE TIME OF HER CALL TO DEXCOM TECHNICAL SUPPORT, 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 5040859

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other DAYQUIL| NYQUIL