BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5,1 FS CHEMISTRY SYSTEM

    MDR report key: 1150903 · Received September 3, 2008

    Report

    Report Number
    1319681-2008-00263
    Event Type
    Malfunction
    Date Received
    September 3, 2008
    Date of Event
    August 5, 2008
    Report Date
    August 5, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FOUND THAT THE MOST LIKELY CAUSE OF THIS EVENT WAS AN ERROR DURING THE MANUAL PROGRAMMING OF THE SAMPLES INVOLVED. ANALYSIS OF DATA LOG FILES INCLUDING THE EVENT CONCLUDES THAT MANUAL SAMPLE PROGRAMMING OCCURRED FOR THE SAMPLE INVOLVED. THERE IS NO INDICATION THAT THE INSTRUMENT MALFUNCTIONED. IT IS UNK HOW THE ERROR WAS DETECTED AND WHETHER OR NOT THE RESULTS WERE REPORTED OUT OF THE LABORATORY. THE ROOT CAUSE OF THE EVENT IS USER ERROR.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED MULTIPLE ASSAY RESULTS THAT WERE ASSOCIATED WITH THE WRONG SAMPLE ID WHEN USING THE VITROS 5,1 FS ANALYZER. MIS-ASSOCIATION OF PATIENT RESULTS WITH THE WRONG SAMPLE ID MAY 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 5,1 FS CHEMISTRY SYSTEM CLINICAL CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1