BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.8% RESOLVE PANEL A

    MDR report key: 788458 · Received November 21, 2006

    Report

    Report Number
    2250051-2006-50501
    Event Type
    Malfunction
    Date Received
    November 21, 2006
    Date of Event
    October 30, 2006
    Report Date
    November 21, 2006
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KZS
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A PT SAMPLE CONTAINING ANTI-FYB DID NOT TO REACT WITH FYB POSITIVE CELLS OF 0.8% RESOLVE PANEL A LOT 8RA201. NO DEATH OR SERIOUS INJURY IS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 0.8% RESOLVE PANEL A REAGENT RED BLOOD CELLS KZS ORTHO-CLINICAL DIAGNOSTICS NA 8RA201

    Patients

    Seq Age Sex Outcome Treatment
    1 *