BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORTHO SUMMIT PROCESSOR

    MDR report key: 805748 · Received October 31, 2005

    Report

    Report Number
    2250051-2005-50496
    Event Type
    Other
    Date Received
    October 31, 2005
    Date of Event
    September 30, 2005
    Report Date
    October 28, 2005
    Manufacturer
    HAMILTON BONADUZ AG
    Product Code
    JJE
    Report Source
    Distributor report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ORTHO SUMMIT PROCESSOR (OSP) INSTRUMENT REPORTEDLY STOPPED PROCESSING A MICROWELL PLATE FOR 54 MINS BETWEEN THE END OF THE FINAL INCUBATION FOR A PLATE RUN AND THE ADDITION OF THE STOP REAGENT ADDITION IN THE SPECTROPHOTOMETER MODULE OF THE OSP. THE OSP SPONTANEOUSLY STARTED AGAIN AFTER THE 54 MINS, ADDED THE STOP SOLUTION, READ THE PLATE, AND REPORTED SPECTROPHOTOMETER READINGS WITHOUT AN ERROR MESSAGE INDICATING THAT THE PROCESSING RUN HAD EXPERIENCED AN INTERRUPTION IN PROCESSING. PLATES ARE SUPPOSED TO FINISH INCUBATING AND MOVE TO THE SPECTROPHOTER MODULE FOR THE IMMEDIATE ADDITION OF STOP SOLUTION FOLLOWED BY A PHOTOMETER READ. FAILURE OF THE OSP TO ADD STOP SOLUTION FOR 54 MINS AFTER THE PLATE IS MOVED TO THE SPECTROPHOTOMETER WITHOUT AN ERROR MESSAGE IS UNEXPECTED. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO SUMMIT PROCESSOR ELISA MICROWELL PLATE PROCESSOR JJE HAMILTON BONADUZ AG 7003015 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other