BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.8% RESOLVE PANEL A

    MDR report key: 1140404 · Received June 12, 2008

    Report

    Report Number
    2250051-2008-70303
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    May 22, 2008
    Report Date
    June 12, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED NO REACTIVITY WITH VRA115 CELLS 2 AND 7 (JKA-B+) AND A PT SAMPLE CONTAINING ANTI-JKB. CUSTOMER STATED THAT THE ANTIBODY SCREEN WAS POSITIVE, HOWEVER, ONLY VRA115 CELL 5 REACTED. ADD'L TESTING WAS PERFORMED AND AN ANTI-JKB SHOWING DOSAGE WAS IDENTIFIED. CUSTOMER REVIEWED RESULTS WITH VRA1115 AND OBSERVED THAT CELLS 2 AND 7 WERE JKA-B+ AND DID NOT REACT. CUSTOMER STATED NO REPORTS OF ANY DISCREPANCIES WITH ANY OTHER PTS OR WITH QC TESTING. NO ERRONEOUS RESULTS WERE REPORTED. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 0.8% RESOLVE PANEL A REAGENT RED BLOOD CELLS KSZ ORTHO-CLINICAL DIAGNOSTICS NA VRA1115

    Patients

    Seq Age Sex Outcome Treatment
    1 *