BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD PARADIGM LINK BLOOD GLUCOSE MONITOR

    MDR report key: 650006 · Received December 7, 2005

    Report

    Report Number
    2243072-2005-00478
    Event Type
    Injury
    Date Received
    December 7, 2005
    Date of Event
    November 8, 2005
    Report Date
    December 7, 2005
    Manufacturer
    BECTON DICKINSON
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CONSUMER CALLED TO REPORT HAVING A SPELL THE PREVIOUS EVENING, SWEATING AND CONVULSING, WAS TREATED BY PARAMEDICAL TEAM WITH 2 SHOTS OF GLUCOGON AND OJ WITH SUGAR. METER READING WAS NOT TAKEN AT THE TIME, BUT 30 MINUTES LATER, READING WAS 120.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD PARADIGM LINK BLOOD GLUCOSE MONITOR BD TEST STRIPS NBW BECTON DICKINSON NA 4064348

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other| R