BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1241615 · Received November 19, 2008

    Report

    Report Number
    1056600-2008-00337
    Event Type
    Malfunction
    Date Received
    November 19, 2008
    Date of Event
    October 27, 2008
    Report Date
    November 19, 2008
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    AN OCD FIELD ENGINEER ARRIVED ON SITE AND FOUND THE WASH STATION WAS CRACKED. REPLACEMENT OF THE WASH STATION AND PROBE HAS RETURNED THE ANALYZER TO EXPECTED OPERATION. IT IS UNKNOWN HOW THE REAGENTS BECAME CONTAMINATED. THE CUSTOMER DID NOT OBSERVE ANY PROBE ISSUES. THIS CUSTOMER HAS NOT LOGGED ANY COMPLAINTS AGAINST THIS ANALYZER SINCE THIS INCIDENT. INCIDENT IS ISOLATED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY OBSERVED A FALSE POSITIVE TEST INTERPRETATION WHILE PERFORMING ANTIBODY SCREEN TESTING ON THE ORTHO PROVUE ANALYZER. THE CUSTOMER INDICATED THAT THE REAGENTS ON BOARD THE INSTRUMENT WERE CONTAMINATED. NO ERRONEOUS RESULTS WERE REPORTED

    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