BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-D FOR SLIDE AND MODIFIED TUBE TESTS

    MDR report key: 1570368 · Received December 28, 2009

    Report

    Report Number
    2250051-2009-00381
    Event Type
    Malfunction
    Date Received
    December 28, 2009
    Date of Event
    January 23, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETAINED TESTING WAS NOT PERFORMED DUE TO EXPIRATION OF PRODUCT. CUSTOMER REPORTED THAT QC TESTING WAS SATISFACTORY AT TIME OF INCIDENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED WEAK FALSE POSITIVE RESULTS (1+) IN THE WEAK D PHASE WITH ONE PT SAMPLE. NO ERRONEOUS RESULTS WERE REPORTED. QC TESTING PERFORMED BY CUSTOMER WAS SATISFACTORY. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-D FOR SLIDE AND MODIFIED TUBE TESTS BLOOD GROUPING REAGENTS KSZ ORTHO-CLINICAL DIAGNOSTICS, INC. DS701A2

    Patients

    Seq Age Sex Outcome Treatment
    1