BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3910707 · Received July 2, 2014

    Report

    Report Number
    3004753838-2014-05768
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 12, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P050012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 AND CLAIMED THAT ON (B)(6) 2014 THAT PATIENT EXPERIENCED A HYPOGLYCEMIC EVENT AND LOST CONSCIOUSNESS. PATIENT'S HUSBAND CONTACTED AND, UPON ARRIVAL, ADMINISTERED GLUCOSE TO PATIENT. PATIENT STATED THAT THEY DID NOT RECALL IF DEVICE ALERTED OR NOT. NO FURTHER MEDICAL INTERVENTION WAS NECESSARY. AT THE TIME OF THE CALL WITH DEXCOM TECHNICAL SUPPORT, PATIENT REPORTED FEELING GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386950 SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-03

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other