BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    MDR report key: 2963120 · Received February 15, 2013

    Report

    Report Number
    2250051-2013-00028
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 10, 2013
    Report Date
    February 15, 2013
    Manufacturer
    HAMILTON BONADUZ AG
    Product Code
    MMH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS BEEN INVESTIGATED. ON (B)(4) 2013 AN OCD FIELD ENGINEER ARRIVED AT THE CUSTOMER SITE AND REVIEWED ALL THE BARCODE SETTINGS FOR THE INSTRUMENT AND FOR THE SERVER. THE SERVER WAS SET TO ALL BARCODE TYPES. THIS SETTING PER THE USER MANUAL HAS NO DATA FORMAT VALIDATIONS. THE FE CHANGED THE SETTINGS TO CODABAR IN THE SERVER. THE FE RAN BOTH CODABAR AND ISBT ON THE PIPETTER WITH NO ISSUES. REPAIRS HAVE RETURNED THIS INSTRUMENT TO EXPECTED OPERATION.

    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
    67978 ORTHO SUMMIT SAMPLE HANDLING SYSTEM SAMPLE PIPETTOR MMH HAMILTON BONADUZ AG 936400

    Patients

    Seq Age Sex Outcome Treatment
    1