BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORTHO ELISA BAR CODE READER II

    MDR report key: 76742 · Received February 18, 1997

    Report

    Report Number
    2250051-1997-00005
    Event Type
    Other
    Date Received
    February 18, 1997
    Date of Event
    January 9, 1997
    Report Date
    February 14, 1997
    Manufacturer
    INTERMEC CORP. GREENBROOK CORPORATE CENTER
    Product Code
    JQW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE RUNNING A HEPATITIS CORE ASSAY, THE BAR CODE READER MISREAD A SAMPLE BARCODE. THE BARCODE WAS READ AS "6010213" INSTEAD OF "6011213". AN INVESTIGATION IS IN PROGRESS. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other