BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO RESOLVE PANEL A

    MDR report key: 1831713 · Received September 13, 2010

    Report

    Report Number
    2250051-2010-00207
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    June 21, 2010
    Report Date
    September 13, 2010
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT WAS RECEIVED BEYOND DATING OF PRODUCT, THEREFORE NO TESTING WAS PERFORMED. (B)(4).

    Description of Event or Problem · 1

    ACCOUNT REPORTS THAT THEY MISSED AN ANTI-E ON A NEW YORK STATE SAMPLE (JUNE 21 PT EVENT - 2ND EVENT - SAMPLE ID (B)(6)). ACCOUNT INITIALLY TESTED SAMPLE USING RESOLVE PANEL A LOT RA743 (EXPIRED (B)(6) 2010). ACCOUNT IDENTIFIED AN ANTI-C AND REPORTED THE RESULT TO THE STATE. RESULTS OF THE PROFICIENCY TEST INDICATE THAT THE SAMPLE CONTAINED AN ANTI-E, NOT AN ANTI-C.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1