BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1022390 · Received March 27, 2008

    Report

    Report Number
    1056600-2008-00099
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    February 29, 2008
    Report Date
    March 27, 2008
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD ENGINEER, CONTACTED THE CUSTOMER VIA TELEPHONE. THE CUSTOMER INDICATED THERE WERE NO ISSUES, AND THE PROVUE IS RUNNING AS EXPECTED. THE CUSTOMER HAS NOT LOGGED ANY ADDITIONAL CALLS REGARDING THIS ISSUE, SINCE THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ORTHO PROVUE ANALYZER REPORTED FALSE NEGATIVE RESULTS. THE VISUAL INSPECTION OF THE PROCESSED GEL CARDS SHOWED THE REACTIONS WERE NEGATIVE. NO ERRONEOUS TEST RESULTS WERE REPORTED. FALSE NEGATIVE TEST RESULTS CAN LEAD TO TRANSFUSION OF INCOMPATIBLE BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO PROVUE AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYST KSZ MICRO TYPING SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1