BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    MDR report key: 3111480 · Received May 14, 2013

    Report

    Report Number
    2250051-2013-00133
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 18, 2013
    Report Date
    May 14, 2013
    Manufacturer
    HAMILTON BONADUZ AG
    Product Code
    MMH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013 AN OCD FIELD ENGINEER (FE) ARRIVED AT THE CUSTOMER SITE AND PERFORMED SEVERAL LLD CHECKS IN DIAGNOSTIC SOFTWARE AND NOTICED THE TIPS WERE ALMOST RUBBING ON THE FRONT EDGE OF THE TUBES. THE FE ADJUSTED THE X-ARM SO THAT THE TIPS WOULD BE MORE CENTERED IN THE TUBES. THE FE PERFORMED ALL X-ARM CALIBRATIONS AND SEVERAL SUCCESSFUL LLD CHECKS IN DIAGNOSTIC SOFTWARE TO CONFIRM PROPER OPERATION. REPAIRS HAVE RETURNED THIS INSTRUMENT TO EXPECTED OPERATION.

    Description of Event or Problem · 1

    THE ORTHO SUMMIT SAMPLE HANDLING SYSTEM INSTRUMENT DID NOT PIPETTE THE CORRECT AMOUNT OF SAMPLE AND DID NOT GENERATE AN ERROR MESSAGE. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211753 ORTHO SUMMIT SAMPLE HANDLING SYSTEM SAMPLE PIPETTOR MMH HAMILTON BONADUZ AG 936400

    Patients

    Seq Age Sex Outcome Treatment
    1