BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    MDR report key: 3181958 · Received June 21, 2013

    Report

    Report Number
    2250051-2013-00171
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 23, 2013
    Report Date
    June 21, 2013
    Manufacturer
    HAMILTON BONADUZ AG
    Product Code
    MMH
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013 AN OCD FIELD ENGINEER (FE) ARRIVED AT THE CUSTOMER SITE AND INSPECTED ALL TIP AND PLUNGER CLAMPS. THE FE OBSERVED PLUNGER CLAMP IN POSITION # 12 HAS STUCK EJECTION PIN. THE FE CLEANED PLUNGER CLAMP IN POSITION # 12. THE FE TESTED LLD WITH SPLLD TEST. THE FE TESTED THE SUMMIT WITH (B)(4) SOFTWARE TEST. ALL TESTS PASSED. REPAIRS HAVE RETURNED THIS INSTRUMENT TO EXPECTED OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT LOW SAMPLE WAS PIPETTED INTO COLUMN 12 WHILE PIPETTING OF HCV ASSAY. NO ERRONEOUS RESULTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281675 ORTHO SUMMIT SAMPLE HANDLING SYSTEM SAMPLE PIPETTOR MMH HAMILTON BONADUZ AG 936400

    Patients

    Seq Age Sex Outcome Treatment
    1