BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 350 CHEMISTRY SYSTEM

    MDR report key: 1840605 · Received September 21, 2010

    Report

    Report Number
    1319681-2010-00200
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 23, 2010
    Report Date
    September 21, 2010
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS THEO RESULTS OCCURRED ON DILUTED CONTROL FLUIDS PROCESSED ON THE VITROS 350 CHEMISTRY SYSTEM. AN OCD FIELD SERVICE ENGINEER ADJUSTED THE DILUTION CUP MODULE TO MITIGATE THE ISSUE AND RETURN THE SYSTEM TO EXPECTED OPERATION. SUBSEQUENT PHYT RESULTS ON THE DILUTED CONTROL FLUIDS WERE ACCEPTABLE. THE ROOT CAUSE OF THE EVENT IS INSTRUMENT RELATED.

    Description of Event or Problem · 1

    THIS CUSTOMER OBSERVED LOWER THAN EXPECTED THEOPHYLLINE QUALITY CONTROL RESULTS WHILE USING VITROS CHEMISTRY PRODUCTS THEO SLIDES WHEN PROCESSED ON A VITROS 350 CHEMISTRY SYSTEM. BIASED PATIENT RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION SHOULD THEY OCCUR ON PATIENT SAMPLES. 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 350 CHEMISTRY SYSTEM CLINICAL CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1