BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.8% RESOLVE PANEL A

    MDR report key: 1832638 · Received September 13, 2010

    Report

    Report Number
    2250051-2010-00209
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 24, 2010
    Report Date
    September 13, 2010
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    OCD PERFORMED RETAINED TESTING OF THE PRODUCT. SATISFACTORY RESULTS WERE OBSERVED. A BATCH REVIEW WAS ALSO PERFORMED. ALL RESULTS WERE SATISFACTORY. PRODUCT CONTINUES TO PERFORM AS INTENDED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PATIENT SAMPLE WITH NO PREVIOUS HISTORY AND A POSITIVE ANTIBODY SCREEN DID NOT REACT WITH CELL 2 (K+K+). CELL 7 (K+K+) WAS WEAKLY POSITIVE. ADDITIONAL TESTING WITH ANOTHER PANEL LATER IDENTIFIED AN ANTI-KELL.

    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