BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1153325 · Received July 2, 2008

    Report

    Report Number
    2250051-2008-00308
    Event Type
    Malfunction
    Date Received
    July 2, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    KSZ
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    ORTHO-CLINICAL DIAGNOSTICS (OCD) QUALITY ASSURANCE PERFORMED RETAINED TESTING TO CONFIRM THE REACTIVITY. RESULTS WERE SATISFACTORY. THE PT RETURN SAMPLE WAS EVALUATED AND WEAK REACTIVITY WAS OBSERVED. A REVIEW OF THE BATCH RECORD CONFIRMED THE PROD MET ALL RELEASE SPECS PRIOR TO RELEASE. THE CUSTOMER CONCLUDED THE ISSUE WAS SAMPLE RELATED AS NO OTHER REPORTED DISCREPANCIES AND CONTINUED ACCEPTABLE QC RESULTS. RELATED COMPLAINTS FOR THIS ISSUE HAVE BEEN RECORDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * KSZ ORTHO-CLINICAL DIAGNOSTICS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1