BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 950 CHEMISTRY SYSTEM

    MDR report key: 1203386 · Received October 14, 2008

    Report

    Report Number
    1319681-2008-00307
    Event Type
    Malfunction
    Date Received
    October 14, 2008
    Date of Event
    September 19, 2008
    Report Date
    September 19, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT THE CALIBRATION RESPONSES AND PARAMETERS WERE ATYPICAL COMPARED TO THE EXPECTED VALUES. AMMONIA PRECISION TEST RESULTS WERE WITHIN THE EXPECTED INTERVAL. FURTHER INVESTIGATION CONCLUDED THAT THE LAB WAS EXPERIENCING AMBIENT TEMPERATURE SHIFTS OF GREATER THAN 5 DEGREES. THE MANUFACTURER INDICATES THAT CALIBRATION MAY BE REQUIRED IF AMBIENT TEMPERATURE SHIFTS GREATER THAN 5 DEGREES. STABILIZING TEMPERATURE WITH THE 5 DEGREE INTERVAL RESOLVED THE CONCERN. THE ROOT CAUSE OF THE EVENT IS USER ERROR.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED HIGHER THAN EXPECTED QUALITY CONTROL RESULTS WHEN USING VITROS AMON SLIDES ON THE VITROS 950 ANALYZER. NO PATIENT SAMPLES WERE REPORTED WHILE QUALITY CONTROL RESULTS WERE UNACCEPTABLE. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS 950 CHEMISTRY SYSTEM CLINICAL CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1