BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD LINK METERS

    MDR report key: 1061881 · Received June 18, 2008

    Report

    Report Number
    MW5007349
    Event Type
    Injury
    Date Received
    June 18, 2008
    Date of Event
    June 16, 2008
    Report Date
    June 17, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAS BEEN USING BD LINK BLOOD GLUCOSE METERS FOR 2.5 YEARS, IN CONJUNCTION WITH A 515 PARADIGM MEDTRONIC INSULIN PUMP. SHE REPORTED RECENT EPISODES OF PASSING OUT AND DKA. ACCURACY OF METERS VERIFIED WITH OFFICE HEMOCUE BD # 1 159 MG/DL. BD # 2 143 MG/DL, HEMOCUE 81 MG/DL. PRODUCTS DISCONTINUED FOR OLD AND NEW ULTRA METERS GIVEN WITH ACCURACY VERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD LINK METERS GLUCOSE METERS NBW MEDTRONIC MINIMED
    2 BD LINK METERS GLUCOSE METERS NBW MEDTRONIC MINIMED

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening