BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS PK7200 AUTOMATED BLOOD BANK ANALYZER

    MDR report key: 610059 · Received May 25, 2005

    Report

    Report Number
    8010047-2005-00048
    Event Type
    Malfunction
    Date Received
    May 25, 2005
    Date of Event
    April 22, 2005
    Report Date
    May 25, 2005
    Manufacturer
    OLYMPUS CORPORATION
    Product Code
    KSZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT PLASMA SAMPLE TESTED SYPHILIS NEGATIVE WITH QUESTIONABLE VISUAL DETERMINATION. SAMPLE WAS DISCARDED THEREFORE UNABLE TO CONFIRM BY FTA TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS PK7200 AUTOMATED BLOOD BANK ANALYZER AUTOMATED BLOOD BANK ANALYZER KSZ OLYMPUS CORPORATION PK7200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other