BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD PARDIGM LINK BLOOD GLUCOSE MONITOR

    MDR report key: 722643 · Received June 5, 2006

    Report

    Report Number
    2243072-2006-00214
    Event Type
    Injury
    Date Received
    June 5, 2006
    Date of Event
    May 14, 2006
    Report Date
    June 5, 2006
    Manufacturer
    BECTON DICKINSON
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CONSUMER CALLED TO REPORT HIGH READINGS THAT RESULTED IN HER HOSPITALIZATION. WAS HAVING LOW SUGAR REACTION AND HER METER WAS READING 95. CONSUMER DRANK OJ AND DOESN'T REMEMBER ANYTHING AFTER THAT. PARAMEDICS WERE CALLED AND THEY GOT READINGS OF 42, 53, 64.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD PARDIGM LINK BLOOD GLUCOSE MONITOR BD TEST STRIPS NBW BECTON DICKINSON NA 4064195

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other| R