BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO ELISA BAR CODE READER II

    MDR report key: 242532 · Received September 22, 1999

    Report

    Report Number
    2250051-1999-00831
    Event Type
    Malfunction
    Date Received
    September 22, 1999
    Date of Event
    August 18, 1999
    Report Date
    August 26, 1999
    Manufacturer
    INTERMEC CORP.
    Product Code
    JTC
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED, WHILE USING A HAND HELD INTERMEC BARCODE WAND, READ A SAMPLE BARCODE AS 138360413 INSTEAD OF 013LG60413. A HEPATITIS CORE ASSAY WAS BEING RUN AT THE TIME. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO-CLINICAL DIAGNOSTICS COMPLAINT NUMBER 99-03591-08.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO ELISA BAR CODE READER II BAR CODE READER JTC INTERMEC CORP. 9720C01, D01, E01, F01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other