BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO SAMPLE PROCESSOR

    MDR report key: 1232063 · Received September 3, 2008

    Report

    Report Number
    2250051-2008-80427
    Event Type
    Malfunction
    Date Received
    September 3, 2008
    Date of Event
    August 20, 2008
    Report Date
    September 3, 2008
    Manufacturer
    HAMILTON BONADUZ AG
    Product Code
    JTC
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ORTHO SUMMIT PROCESSOR INSTRUMENT DELIVERED INCORRECT VOLUME TO THE FIRST 3 ROWS OF A T. CRUZI PLATE AND DID NOT GENERATE AN ERROR MESSAGE. THE CUSTOMER INVALIDATED THE PLATE AND REPROCESSED THE SAMPLES FROM THE MICROPLATE SUCCESSFULLY. NO ERRONEOUS RESULTS WERE REPORTED. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO SAMPLE PROCESSOR ORTHO SAMPLE PRECESSOR JTC HAMILTON BONADUZ AG 936480 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *