BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.8% SURGISCREEN

    MDR report key: 1945977 · Received January 4, 2011

    Report

    Report Number
    2250051-2011-00004
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    December 23, 2010
    Report Date
    January 4, 2011
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OCD PERFORMED RETAINED TESTING AND A BATCH RECORD REVIEW. SATISFACTORY RESULTS WERE OBSERVED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED NO REACTIVITY OBSERVED DURING AN ANTIBODY SCREEN WITH A PATIENT WITH A KNOWN ANTI-KELL. THE CUSTOMER INDICATES THAT TESTING WAS DONE IN MANUAL GEL WITH 15 MINUTE INCUBATION. REPEAT TESTING WAS PERFORMED WITH 30 MINUTE INCUBATION. NO REACTIVITY OBSERVED. NO DISCREPANCIES NOTED IN THE DAILY QC ON ANY DAY OF TESTING WITH THE PRODUCT. THE CUSTOMER INDICATES THAT THEY ARE CONFIDENT THAT THE DESCRIBED FALSE NEGATIVE RESULT WAS RELATED TO THE PATIENT'S SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 0.8% SURGISCREEN REAGENT RED BLOOD CELLS KSZ ORTHO CLINICAL DIAGNOSTICS VSS352

    Patients

    Seq Age Sex Outcome Treatment
    1