BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 2801979 · Received October 23, 2012

    Report

    Report Number
    1319681-2012-00212
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    September 23, 2012
    Report Date
    October 23, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT IMPRECISE VITROS AMON QUALITY CONTROL RESULTS WERE OBTAINED WHILE USING THE VITROS 5600 INTEGRATED SYSTEM. THERE WAS NO EVIDENCE TO SUGGEST A MALFUNCTION OF THE VITROS AMON REAGENT. RESULTS OF PRECISION TESTING DEMONSTRATED THAT THE VITROS 5600 INTEGRATED SYSTEM WAS NOT PERFORMING AS EXPECTED AT THE TIME OF THE EVENT. THE CUSTOMER PERFORMED INCUBATOR MAINTENANCE AS DESCRIBED IN THE VITROS 5600 MAINTENANCE AND DIAGNOSTIC GUIDE. ACCEPTABLE VITROS AMON QUALITY CONTROL PERFORMANCE WAS OBSERVED FOLLOWING COMPLETION OF THE MAINTENANCE ACTIVITIES. THE ROOT CAUSE OF THIS EVENT IS MOST LIKELY INSTRUMENT RELATED.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED IMPRECISE VITROS AMON QUALITY CONTROL RESULTS WHILE USING THE VITROS 5600 INTEGRATED SYSTEM. HIGHER THAN EXPECTED VITROS AMON QUALITY CONTROL RESULTS OF 500.0, 107.6, 102.8, 104.9 MOL/L VS. AN EXPECTED RESULT OF 46.2 MOL/L WERE OBTAINED USING VITROS LPVI AND A QUALITY CONTROL RESULT OF 259.9 MOL/L VS. AN EXPECTED RESULT OF 194.0 MOL/L WAS OBTAINED USING VITROS LPV II. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED USING PATIENT SAMPLES. NO PATIENT SAMPLES WERE AFFECTED OR REPORTED FROM OUT OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1