BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO-CLINICAL DIAGNOSTICS

    MDR report key: 756482 · Received August 24, 2006

    Report

    Report Number
    MW1040176
    Event Type
    Malfunction
    Date Received
    August 24, 2006
    Report Date
    August 24, 2006
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO THIS OFFICE THAT A REAGENT THAT IS BEING USED WILL NOT PICK UP CERTAIN ANTIBODIES THAT COULD BE INJURIOUS TO THE PATIENT. IT IS ALSO OUR UNDERSTANDING THE MANUFACTURER IS AWARE OF THIS ISSUE. THIS REPORT IS BEING FILED DUE TO THE SEEMING SLOW RESPONSE OF THE MANUFACTURER TO THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO-CLINICAL DIAGNOSTICS RED BLOOD CELL REAGENT KSZ ORTHO-CLINICAL DIAGNOSTICS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *