BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    MDR report key: 3002201 · Received March 13, 2013

    Report

    Report Number
    2250051-2013-00077
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 13, 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 INSTRUMENT FOR THE REPORTED ISSUE. THE FE WAS ABLE TO RECREATE THE ISSUE BY PERFORMING THE SPLLD CHECK. THE FE IDENTIFIED THAT TIP #2 WAS NOT BEING HELD TIGHTLY BY THE TIP CLAMPS. FE PERFORMED HOLDING FORCE CHECK ON PLUNGER CLAMP #2; PASSED SPECIFICATION. THE FE THEN CLEANED THE TIP CLAMP SLEEVE AND REPLACED THE TIP CLAMP TO CORRECT THE ISSUE. THE FE PERFORMED SPLLD CHECKING PROCEDURE AND TESTED THE SUMMIT WITH OAS USER SOFTWARE. THE INSTRUMENT WAS TESTED WITHOUT PROBLEM AND RETURNED TO EXPECTED OPERATION.

    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. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105364 ORTHO SUMMIT SAMPLE HANDLING SYSTEM SAMPLE PIPETTOR MMH HAMILTON BONADUZ AG

    Patients

    Seq Age Sex Outcome Treatment
    1