BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORTHO CLINICAL DIAGNOSTICS

    MDR report key: 752082 · Received August 25, 2005

    Report

    Report Number
    MW1036411
    Event Type
    Other
    Date Received
    August 25, 2005
    Date of Event
    August 16, 2005
    Report Date
    August 19, 2005
    Manufacturer
    *
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    TWO LOTS OF BLOOD TESTING REAGENT, REC'D IN OUR LAB AT SEPARATE TIMES, APPEAR TO BE DEFECTIVE. ORTHO CLINICAL DIAGNOSTICS "REAGENT RED BLOOD CELLS 0.8% RESOLVE PANEL A" LOTS 8RA185 AND 8RA186 DO NOT POSITIVELY IDENTIFY ANTI-D. THIS PROBLEM WITH LOT 8RA185 WAS REPORTED TO ORTHO CLINICAL DIAGNOSTICS ON 08/17/05. THE PROBEM WITH LOT 8RA186 WAS REPORTED TO ORTHO 08/18/05.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO CLINICAL DIAGNOSTICS REAGENT RED BLOOD CELLS 0.8% RESOLVE PANEL A KSZ * * 8RA185

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other