BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5,1 FS CHEMISTRY SYSTEM

    MDR report key: 1162483 · Received September 9, 2008

    Report

    Report Number
    1319681-2008-00266
    Event Type
    Malfunction
    Date Received
    September 9, 2008
    Date of Event
    August 15, 2008
    Report Date
    August 15, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION INTO THIS EVENT DETERMINED THAT THE ORIGINAL ANALYSIS OF THE PATIENT SAMPLE GENERATED ERROR CODES INDICATED THAT THE SAMPLE WAS LOW IN CONCENTRATION. NO RESULT WAS GENERATED. THE CUSTOMER MISINTERPRETED THE INSTRUMENT ERROR CODES AS AN ELEVATED RESULT AND DILUTED THE SAMPLE. THE DILUTED RESULT AGAIN GENERATED AN INSTRUMENT ERROR CODE INDICATING THE SAMPLE CONCENTRATION WAS LOW AND AGAIN WAS MISINTERPRETED. THE CUSTOMER THEN REPORTED A RESULT AS TWICE THE UPPER END OF THE REPORTABLE RANGE, WHICH WAS INCORRECT. THE INSTRUMENT HAD GENERATED A FLAG THAT DIRECTED THE USER TO CHECK THE ERROR CODES. THE ERROR CODE STATED THE SAMPLE CONCENTRATION WAS LOW AND SHOULD NOT HAVE BEEN DILUTED. THE INVESTIGATION INTO THIS EVENT CONCLUDES THAT THE ROOT CAUSE WAS OPERATOR ERROR.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED A POSITIVELY BIASED VITROS PHYT RESULT FROM A PATIENT SAMPLE ON A VITROS 5, 1 FS ANALYZER. THE CUSTOMER STATES THE RESULTS WERE REPORTED AND THEN QUESTIONED BY THE PATIENT'S PHYSICIAN BUT THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. A REPEAT TEST OF THE SAME SAMPLE PRODUCED A NEGATIVE RESULT. THIS REPORT CORRESPONDS TO ORTHO-CLINICAL DIAGNOSTICS, INC.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1