BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORTHO SUMMIT TM SAMPLE HANDLING SYSTEM

    MDR report key: 117340 · Received August 28, 1997

    Report

    Report Number
    2250051-1997-00065
    Event Type
    Other
    Date Received
    August 28, 1997
    Date of Event
    July 16, 1997
    Report Date
    August 25, 1997
    Manufacturer
    HAMILTON BONADUZ AG
    Product Code
    JTC
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO ORTHO ON 8/11/97 THAT AN INCIDENT OCCURRED ON 7/16/97. WHILE RUNNING AN ANTIBODY SCREENING ASSEY, SUMMIT SAMPLE HANDLER, MISREAD A SAMPLE BARCODE IN POSITION B5 AS "8779969" INSTEAD OF "8779963". NO ERROR MESSAGE WAS GENERATED. THE CUSTOMER ALSO STATED THAT THIS HAD ALSO OCCURRED PREVIOUSLY, ON 6/18/97 WHEN A BARCODE WAS READ AS "8701241" INSTEAD OF "8701240". NO ERROR MESSAGE WAS GIVEN. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO DIAGNOSTIC SYSTEMS COMPLAINT NUMBER 97-04024-08. THE BARCODE FROM THE 7/16/97 INCIDENT HAS BEEN RETURNED TO ORTHO FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO SUMMIT TM SAMPLE HANDLING SYSTEM SAMPLE HANDLER JTC HAMILTON BONADUZ AG 135028 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other