BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5, 1 FS CHEMISTRY ANALYZER

    MDR report key: 1060718 · Received June 10, 2008

    Report

    Report Number
    1319681-2008-00172
    Event Type
    Malfunction
    Date Received
    June 10, 2008
    Date of Event
    May 10, 2008
    Report Date
    May 12, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS CONCLUDED THAT OPERATOR ERROR IS THE MOST LIKELY CAUSE OF THE FALSELY ELEVATED PHBR RESULTS. THERE IS NO EVIDENCE TO SUGGEST THAT THE INSTRUMENT OR THE REAGENT WAS NOT OPERATING AS INTENDED. THE PHBR RESULT OBTAINED BY THE VITROS 5,1 ANALYZER WAS ACCURATE HOWEVER THE VITROS 5, 1 RESULTS CONFIGURATION WAS SET BY THE OPERATOR TO ALLOW ONLY ONE DIGIT (OTHER THAN ZERO) TO BE PROVIDED. THE PHBR RESULTS CONFIGURATION CAUSED THE FALSELY ELEVATED PHBR RESULTS TO BE OBTAINED FOR AN OTHERWISE ACCURATELY PRODUCED PHBR RESULT. ONCE THE PHBR RESULTS CONFIGURATION WAS APPROPRIATELY RESET, THE EXPECTED PHBR RESULTS WERE OBTAINED.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED A FALSELY ELEVATED PHBR RESULT ON A SINGLE NYS PROFICIENCY SAMPLE ON THE VITROS 5,1 ANALYZER. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THERE WAS NO REPORT OF PT HARM AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS 5, 1 FS CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1