BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 3071234 · Received April 22, 2013

    Report

    Report Number
    1319681-2013-00087
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 7, 2013
    Report Date
    April 22, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT MULTIPLE, NON-REPRODUCIBLE, UNEXPECTED VITROS AMON QUALITY CONTROL RESULTS WERE OBTAINED ON A VITROS 5600 INTEGRATED SYSTEM. AN OCD FIELD ENGINEER REPLACED THE CM/RT INCUBATOR ROTOR, UPDATED CORRECTION FACTORS, AND COMPLETED A PREVENTATIVE MAINTENANCE PROCEDURE FOR THE MICROSLIDE PROCESSING SUBSYSTEMS WHICH INCLUDES INCUBATOR CLEANING TO RETURN EXPECTED PERFORMANCE. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY ROOT CAUSE OF THE EVENT IS ANALYZER RELATED DUE TO MICROSLIDE INCUBATOR CONTAMINATION. THERE WAS NO EVIDENCE THAT A REAGENT RELATED ISSUE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED MULTIPLE, NON-REPRODUCIBLE, UNEXPECTED, VITROS AMON QUALITY CONTROL RESULTS ON A VITROS 5600 INTEGRATED SYSTEM. QC FLUID LOT C1730 = 114.7, 158.7, 90.1, 97.0, 119.2 VS. AN EXPECTED RESULT = 43.3 MMOL/L; QC FLUID LOT D1731 = 82.1, 8.8 VS. AN EXPECTED RESULT = 188.0 MMOL/L; BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THERE WAS NO REPORT THAT PATIENT SAMPLES WERE AFFECTED. 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
    171718 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1