BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OAS 400 MHZ WORKSTATION

    MDR report key: 448612 · Received March 13, 2003

    Report

    Report Number
    2250051-2003-00659
    Event Type
    Malfunction
    Date Received
    March 13, 2003
    Date of Event
    February 20, 2003
    Report Date
    March 11, 2003
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JTC
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SAMPLE ID 009 P97017 WAS INCORRECTLY IDENTIFIED ON THE PLATE REPORT AS 009009 P97017 AFTER PIPETTING MICROWELL PLATE BH0458. NO ERROR WAS REPORTED. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT. THIS REPORT CORRESPONDS TO ORTHO-CLINICAL DIAGNOSTICS COMPLAINT NUMBER 00431888.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OAS 400 MHZ WORKSTATION PC JTC ORTHO-CLINICAL DIAGNOSTICS 6901040 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other