BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    MDR report key: 2202270 · Received August 11, 2011

    Report

    Report Number
    2250051-2011-00186
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 20, 2011
    Report Date
    August 11, 2011
    Manufacturer
    HAMILTON BONADUZ AG
    Product Code
    MMH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS BEEN INVESTIGATED. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT AND PERFORMED THE BARCODE SCANNER FUNCTIONAL CHECKS AND DID NOT FIND ANY ISSUES WITH THE INSTRUMENT OR BARCODES. THE INSTRUMENT WAS TESTED WITHOUT PROBLEM AND WAS RETURNED TO EXPECTED OPERATION. CUSTOMER WILL MONITOR FOR ADDITIONAL EVENTS.

    Description of Event or Problem · 1

    THE BARCODE SCANNER ON THE ORTHO SUMMIT SAMPLE HANDLING SYSTEM INSTRUMENT MISREAD THE SAMPLE BARCODE. A BARCODE MISREAD COULD RESULT IN A SAMPLE FROM ONE PATIENT BEING MISINTERPRETED FOR ANOTHER. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1