BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD PARADIGM LINK BLOOD GLUCOSE METER

    MDR report key: 537332 · Received August 2, 2004

    Report

    Report Number
    2243072-2004-00430
    Event Type
    Injury
    Date Received
    August 2, 2004
    Date of Event
    July 2, 2004
    Report Date
    August 2, 2004
    Manufacturer
    BECTON DICKINSON
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CONSUMER REPORTS ACCURACY CONCERNS WITH THEIR PLINK METER. STATES THEY RECEIVED ELEVATED READINGS AND THEY FELT THEIR BLOOD SUGAR WAS EXTREMELY LOW. WENT TO THE DR, WAS GIVEN A LARGE AMOUNT OF OJ TO ELEVATE THEIR BLOOD SUGAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD PARADIGM LINK BLOOD GLUCOSE METER BD TEST STRIPS NBW BECTON DICKINSON NA 4064008

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention