BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    MDR report key: 1456898 · Received August 14, 2009

    Report

    Report Number
    2250051-2009-00256
    Event Type
    Malfunction
    Date Received
    August 14, 2009
    Date of Event
    August 12, 2009
    Report Date
    August 14, 2009
    Manufacturer
    HAMILTON BONADUZ AG
    Product Code
    JTC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS BEEN INVESTIGATED. CUSTOMER FOUND A DAMAGED TIP. THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND DETERMINED TIP DAMAGE OCCURRED DURING TIP TAKE-UP. FSE ALSO FOUND PLUNGER CLAMP IN POSITION #12 HAS A DAMAGED/BENT TOOTH. FSE REPLACED THE PLUNGER CLAMP AND PERFORMED MULTIPLE TIP TAKE UP IN DIAGNOSTICS. FSE FOUND TIP INTERMITTENTLY NOT BEING PICKED UP PROPERLY IN POSITION #12 AND ADJUSTED TIP TAKE-UP POSITION BY 1 STEP IN X AND Y DIRECTION. FSE ADJUSTED TIP TAKE-UP FLAP FOR PROPER HOLDING POSITION AGAINST TIP CONVEYOR. THE INSTRUMENT WAS TESTED WITHOUT FURTHER PROBLEM AND WAS RETURNED TO EXPECTED OPERATION.

    Description of Event or Problem · 1

    THE ORTHO SUMMIT SAMPLE HANDLING SYSTEM INSTRUMENT DID NOT PIPETTE SAMPLE AND REAGENT 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. (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO SUMMIT SAMPLE HANDLING SYSTEM SAMPLE PIPETTER JTC HAMILTON BONADUZ AG 7003009

    Patients

    Seq Age Sex Outcome Treatment
    1