BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 2042469 · Received April 6, 2011

    Report

    Report Number
    1056600-2011-00026
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 8, 2011
    Report Date
    April 6, 2011
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CTS 2ND LEVEL SUPPORT CONFIRMED THE CUSTOMERS' COMPLAINT AND WAS ABLE TO REPRODUCE THE MISREAD IN HOUSE ON THE "DATALOGIC" VERSION OF THE SCANNER. THE OLDER HAND HELD SCANNER BY "HAND HELD PRODUCTS" READS THE LABEL CORRECTLY. THE CUSTOMER WAS INFORMED THAT "WHEN USING THE HAND BARCODE SCANNER TO IDENTIFY SAMPLES, A CHECK HAS TO BE PERFORMED TO VERIFY CONCORDANCE BETWEEN SAMPLE ID LABEL AND READING". THIS ISSUE IS BEING INVESTIGATED. NONCONFORMANCE # (B)(4) WAS OPENED FOR THIS ISSUE. (B)(4)

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ORTHO PROVUE WOULD NOT READ THE BARCODE LABEL SO IT WAS READ MANUALLY WITH THE HANDHELD READER. THE BARCODE WAS READ AS A 9 DIGIT NUMBER # "(B)(4)" INSTEAD OF THE 6 DIGIT # "(B)(4)". NO ERRONEOUS RESULTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO PROVUE AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ MICROTYPING SYSTEMS 3.1.1

    Patients

    Seq Age Sex Outcome Treatment
    1