BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORTHO PROVUE

    MDR report key: 1080998 · Received July 23, 2008

    Report

    Report Number
    1056600-2008-00238
    Event Type
    Other
    Date Received
    July 23, 2008
    Report Date
    July 23, 2008
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER POURED THE WRONG SOLUTION IN THE WRONG BOTTLE. OCD (CTS) ADVISED TO CONSULT THEIR MEDICAL DIRECTOR ON EVALUATION OF THE TEST RESULTS REPORTED AND ON THE REPEAT OF THE SAMPLES TESTED WITH THE WRONG SOLUTION. THE FUNCTIONS OF WASH SOLUTION A AND B WERE ALSO EXPLAINED TO THE CUSTOMER. INSTRUMENT MALFUNCTION DID NOT OCCUR. USER ERROR COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR. THIS CUSTOMER HAS NOT LOGGED ANY SIMILAR COMPLAINTS AGAINST THIS ANALYZER SINCE THIS INCIDENT. INCIDENT IS ISOLATED. (B) (4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY FILLED BOTH WASH SOLUTION A AND B CONTAINERS WITH WASH SOLUTION, A FLUID, AND PERFORMED PATIENT TESTING ON THE ORTHO PROVUE ANALYZER. SAMPLES WERE PROCESSED WITH ONLY WASH SOLUTION A ON ONE SHIFT, WHICH WAS FROM 12-8PM. TEST RESULTS WERE REPORTED. AN INCORRECT WASH SOLUTION USED DURING TESTING MAY CAUSE CARRY-OVER, CROSS CONTAMINATION OR HEMOLYSIS OF REAGENTS OR SAMPLES, WHICH COULD RESULT IN ERRONEOUS TEST RESULTS.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1