BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    MDR report key: 3083286 · Received April 29, 2013

    Report

    Report Number
    2250051-2013-00110
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 29, 2013
    Manufacturer
    HAMILTON BONADUZ AG
    Product Code
    MMH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FE ARRIVED ON SITE AND INVESTIGATED THE REPORTED ISSUE ON THE INSTRUMENT. THE FE INSPECTED THE X ARM AND FOUND THAT THE TIP CLAMPS IN POSITIONS 3 AND 2 SHOWED SIGNS OF WEAR. THE FE REPLACED BOTH TIP CLAMPS. THE FE PERFORMED SPLLD CHECKING PROCEDURE AND TESTED THE SUMMIT WITH (B)(4) USER SOFTWARE. THE INSTRUMENT WAS TESTED WITHOUT PROBLEM. THE INSTRUMENT IS NOW PERFORMING AS EXPECTED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183958 ORTHO SUMMIT SAMPLE HANDLING SYSTEM SAMPLE PIPETTOR MMH HAMILTON BONADUZ AG

    Patients

    Seq Age Sex Outcome Treatment
    1