BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    MDR report key: 3232502 · Received July 18, 2013

    Report

    Report Number
    2250051-2013-00183
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 18, 2013
    Report Date
    July 17, 2013
    Manufacturer
    HAMILTON BONADUZ AG
    Product Code
    MMH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2013, AN OCD FIELD ENGINEER (FE) ARRIVED AT THE CUSTOMER SITE AND INSPECT ALL TIP AND PLUNGER CLAMPS. THE FE REPLACE TIP CLAMP IN POSITION #7 WITH BROKEN PRONG AND INSPECT ALL EJECTION PINS. THE FE TESTED THE SUMMIT LLD WITH SPLLD AND OAS USER SOFTWARE. ALL TESTS PASSED. 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
    333350 ORTHO SUMMIT SAMPLE HANDLING SYSTEM SAMPLE PIPETTOR MMH HAMILTON BONADUZ AG 936400

    Patients

    Seq Age Sex Outcome Treatment
    1