BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 1603912 · Received February 18, 2010

    Report

    Report Number
    1319681-2010-00029
    Event Type
    Malfunction
    Date Received
    February 18, 2010
    Date of Event
    January 21, 2010
    Report Date
    July 23, 2010
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT SHOWED THAT THE EVENT WAS INSTRUMENT RELATED. AN OCD FIELD SERVICE ENGINEER WAS TROUBLESHOOTING A MECHANICAL ISSUE. THE SERVICE ENGINEER DID NOT RETURN THE LUMINOMETER TO THE NORMAL OPERATING MODE, WHICH CAUSED THE ANALYZER TO REPORT THE SAME RESULT FOR ALL ASSAY RESULTS PROCESSED. ALTHOUGH REQUIRED BY THE INSTRUCTIONS FOR USE, QUALITY CONTROL RESULTS WERE NOT PROCESSED BY THE CUSTOMER FOLLOWING SERVICE AND PRIOR TO PROCESSING PATIENT SAMPLES. THE SERVICE ENGINEER RETURNED TO CONFIGURE THE ANALYZER TO THE NORMAL OPERATING MODE, WHICH RESTORED THE INSTRUMENT TO EXPECTED OPERATION. THE ROOT CAUSE OF THE EVENT WAS USER ERROR.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED ERRONEOUS RESULTS FOR MULTIPLE PATIENTS ON MULTIPLE VITROS PRODUCTS WHILE USING THE VITROS 5600 INTEGRATED SYSTEM. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE ORIGINAL RESULTS WERE REPORTED TO THE CLINICIAN, AND CORRECTED REPORTS WERE LATER ISSUED. THERE WAS NO REPORT OF HARM TO PATIENTS AS A RESULT OF THESE EVENTS.THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY SYSTEM JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1