BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3853796 · Received June 6, 2014

    Report

    Report Number
    3004753838-2013-08546
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P050012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2013, TO REPORT A HYPOGLYCEMIC EVENT AND CGM INACCURACIES ON (B)(6) 2013. AT THE TIME OF THE HYPOGLYCEMIC EVENT, THE PATIENT REPORTED THAT SHE HAD BEEN VOMITING AND HER CGM WAS POSSIBLY GENERATING INACCURATE READINGS COMPARED TO HER BLOOD GLUCOSE METER; AT WHICH TIME, THE PATIENT ADMINISTERED GLUCOGON TO HERSELF TO TREAT HER LOW AND SHE ALSO TOOK SOME GLUCOSE TABLETS. THE PATIENT REPORTED THAT SHE CALLED HER DAUGHTER WHO WAS A NURSE AND HER DOCTOR WHO ADVISED HER VIA THE PHONE NOT TO TAKE GLUCOSE TABLETS. AT THE TIME OF THE CALL TO DEXCOM TECHNICAL SUPPORT, THE PATIENT STATED THAT SHE WAS OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332699 SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT20649-PNK 5135334

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other