BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.8% RESOLVE PANEL A

    MDR report key: 1834197 · Received September 14, 2010

    Report

    Report Number
    2250051-2010-00213
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    September 2, 2010
    Report Date
    September 14, 2010
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PATIENT WITH A POSITIVE ANTIBODY SCREEN DID NOT REACT WITH (B)(4). SAMPLE WAS THEN TESTED WITH PEG ENHANCEMENT IN TUBE AND AN ANTI-KELL WAS IDENTIFIED.

    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 VRA146

    Patients

    Seq Age Sex Outcome Treatment
    1