BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO ELISA BAR CODE READER II

    MDR report key: 272323 · Received March 31, 2000

    Report

    Report Number
    2250051-2000-00137
    Event Type
    Malfunction
    Date Received
    March 31, 2000
    Date of Event
    February 21, 2000
    Report Date
    March 16, 2000
    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, DEVICE READ A SAMPLE BARCODE IN POSITION H11 INCORRECTLY AS "018026007" INSTEAD OF "001LC26007". A HTLV-I/II 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 00-01207-03.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other