BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-D FOR SLIDE AND MODIFIED TUBE TESTS

    MDR report key: 1570411 · Received December 28, 2009

    Report

    Report Number
    2250051-2009-00373
    Event Type
    Malfunction
    Date Received
    December 28, 2009
    Date of Event
    November 11, 2009
    Report Date
    December 29, 2009
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ORTHO CLINICAL DIAGNOSTICS (OCD) PERFORMED RETAINED TESTING. SATISFACTORY RESULTS WERE OBSERVED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED FALSE POSITIVE RESULTS (1-2+) 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 DS701D2

    Patients

    Seq Age Sex Outcome Treatment
    1