BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    MDR report key: 2971396 · Received November 20, 2007

    Report

    Report Number
    2250051-2007-00686
    Event Type
    Malfunction
    Date Received
    November 20, 2007
    Date of Event
    October 18, 2007
    Report Date
    November 20, 2007
    Manufacturer
    HAMILTON BONADUZ AG
    Product Code
    JTC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS BEEN INVESTIGATED. THE CUSTOMER IS USING ISBT SAMPLE IDENTIFICATION BAR CODE LABELS, BUT HAD CHANGED THEIR SCANNER SETUP TO READ ALL BARCODE SYMBOLOGY. CUSTOMER TECHNICAL SERVICES EVALUATED THE INSTRUMENT'S BAR CODE SCANNER AND COULD NOT REPRODUCE THE EVENT. THE CUSTOMER RESET THEIR SCANNER TO READ ISBT CODE ONLY. THE INSTRUMENT TESTED W/O FURTHER PROBLEM, AND WAS RETURNED TO SERVICE.

    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 ON PT 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 PIPELTER JTC HAMILTON BONADUZ AG 7003009

    Patients

    Seq Age Sex Outcome Treatment
    1