BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 2874469 · Received December 14, 2012

    Report

    Report Number
    3004753838-2012-00338
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    November 16, 2012
    Report Date
    November 19, 2012
    Manufacturer
    DEXCOM INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    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 ON (B)(6) 2012, HE HAD SUFFERED A HYPOGLYCEMIC EPISODE. PATIENT REPORTS THAT HIS CGM WAS READING AROUND 80 MG/DL BUT HE FELT SYMPTOMATIC. PATIENT DIDN'T MEASURE HIS BG. PATIENT ATE SOME FOOD TO BRING HIS BG UP BUT THE NEXT THING HE REMEMBERED WAS BEING TREATED BY THE PARAMEDICS WITH AN IV AND ORAL GLUCOSE. AFTER TREATMENT, PATIENT'S BG ROSE TO 24 MG/DL WHILE CGM WAS READING 58 MG/DL. AT THE TIME OF HIS 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. 9500-27

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other