BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 2071008 · Received April 27, 2011

    Report

    Report Number
    1319681-2011-00098
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    February 19, 2011
    Report Date
    April 27, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED VITROS LAC QUALITY CONTROL RESULTS WERE OBTAINED ON A VITROS 5600 INTEGRATED SYSTEM. THE INVESTIGATION FOUND NO EVIDENCE TO SUGGEST A REAGENT MALFUNCTION HAD OCCURRED. FOLLOWING RECALIBRATION USING THE SAME VITROS LAC SLIDE LOT, ACCEPTABLE PERFORMANCE WAS OBSERVED. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ASSIGNABLE CAUSE. AN INSTRUMENT ISSUE OR USER ERROR DUE TO IMPROPER REAGENT AND FLUID HANDLING RESULTING IN A NON-OPTIMAL VITROS LAC CALIBRATION CANNOT BE RULED OUT AS CONTRIBUTING FACTORS.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED HIGHER THAN EXPECTED VITROS LACTATE (LAC) QUALITY CONTROL RESULTS WHEN PROCESSED ON THE VITROS 5600 INTEGRATED SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF PATIENT SAMPLES WERE AFFECTED. NO ERRONEOUS PATIENT SAMPLE RESULTS WERE REPORTED FROM THE LABORATORY. 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 5600 INTEGRATED SYSTEM CLINICAL CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1