BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLVE PANEL B

    MDR report key: 846586 · Received December 5, 2006

    Report

    Report Number
    2250051-2006-50530
    Event Type
    Malfunction
    Date Received
    December 5, 2006
    Date of Event
    November 10, 2006
    Report Date
    December 5, 2006
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT TWO PT SAMPLES KNOWN TO CONTAIN ANTI-JSA DID NOT REACT WITH RESOLVE PANEL B LOT RB196 CELL#20. NO DEATH OR SERIOUS INJURY IS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLVE PANEL B REAGENT RED BLOOD CELLS KSZ ORTHO-CLINICAL DIAGNOSTICS NA RB196

    Patients

    Seq Age Sex Outcome Treatment
    1 *