BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 3600 IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 1860559 · Received October 7, 2010

    Report

    Report Number
    1319681-2010-00215
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    September 10, 2010
    Report Date
    October 7, 2010
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KHO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT SID AND RESULTS FROM MULTIPLE PATIENT SAMPLES TESTED ON A VITROS 3600 SYSTEM WERE ASSOCIATED WITH THE INCORRECT PATIENT NAME WHEN PRINTED FROM THE VITROS 3600 SYSTEM. USER ERROR WHILE MANUALLY PROGRAMMING ADDITIONAL TEST REQUESTS FOR AN EXISTING SAMPLE'S PROGRAM WAS DETERMINED TO BE THE ROOT CAUSE. THE VITROS 3600 SYSTEM DID NOT MALFUNCTION.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT SAMPLE IDENTIFICATION NUMBERS (SID) AND RESULTS FROM MULTIPLE PATIENT SAMPLES OBTAINED FROM A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM WERE ASSOCIATED WITH THE INCORRECT PATIENT NAMES. ONLY REPORTS PRINTED FROM THE VITROS 3600 SYSTEM WERE AFFECTED. THE CORRECT SAMPLE WAS TESTED EACH TIME, AND THE RESULTS WERE ASSOCIATED WITH THE CORRECT SID AND UPLOADED TO THE LABORATORY INFORMATION SYSTEM (LIS) WHERE THE SID AND RESULTS WERE ASSOCIATED WITH THE CORRECT PATIENT. NO ERRONEOUS RESULTS WERE REPORTED FROM THE LABORATORY. THE EVENT COULD HAVE LEAD TO ERRONEOUS RESULTS IF THE PRINTED RESULTS ASSOCIATED WITH THE INCORRECT PATIENT NAMES HAD BEEN REPORTED FROM THE LABORATORY. THE ERRONEOUS RESULTS COULD POTENTIALLY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF NOT DETECTED. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS 3600 IMMUNODIAGNOSTIC SYSTEM IMMUNODIAGNOSTIC ANALYZER KHO ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1