BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 3875123 · Received June 16, 2014

    Report

    Report Number
    1319681-2014-00109
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    May 8, 2014
    Report Date
    June 16, 2014
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A NON-REPRODUCIBLE VITROS AMON QUALITY CONTROL RESULT WAS OBTAINED ON A VITROS 5600 INTEGRATED SYSTEM. AN OCD FIELD ENGINEER CLEANED THE MICROSLIDE INCUBATOR AND REPLACED THE INCUBATOR EVAPORATION CAPS TO RETURN THE SYSTEM TO EXPECTED PERFORMANCE. FOLLOWING THESE SERVICE ACTIONS, ACCEPTABLE VITROS AMON PERFORMANCE WAS OBSERVED. THE ROOT CAUSE OF THE EVENT IS MOST LIKELY ANALYZER RELATED DUE TO INCUBATOR CONTAMINATION.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A NON-REPRODUCIBLE VITROS AMON QUALITY CONTROL RESULT (QC LPVII H2768= 148.8 VS. EXPECTED RESULT= 195.0 ¿MOL/L) ON A VITROS 5600 INTEGRATED SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. HOWEVER, NO VITROS AMON PATIENT SAMPLE RESULTS WERE QUESTIONED. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352026 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY SYSTEM JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1