BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5,1 FS CHEMISTRY SYSTEM

    MDR report key: 2104046 · Received May 26, 2011

    Report

    Report Number
    1319681-2011-00122
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    March 17, 2011
    Report Date
    May 26, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT THE CUSTOMER DILUTED THE AFFECTED PROFICIENCY SAMPLE AND OBTAINED A PHYT RESULT OF < 6.0 G/ML. HOWEVER, THE CUSTOMER REPORTED A PHYT RESULT OF < 3.0 G/ML. IN ADDITION, THE CUSTOMER DID NOT FOLLOW THE VITROS PHYT INSTRUCTIONS FOR USE WHEN SELECTING A DILUENT FOR THE DILUTION OF A SAMPLE WHOSE NEAT RESULT WAS LESS THAN THE ANALYZER RANGE (< 3.0 G/ML). THERE IS NO EVIDENCE THAT THE VITROS 5,1 FS CHEMISTRY SYSTEM OR VITROS PHYT REAGENT SLIDES MALFUNCTIONED. THE INVESTIGATION DETERMINED THAT THE ROOT CAUSE OF THE EVENT IS USER ERROR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LOWER THAN EXPECTED VITROS PHYT RESULT (CHM-03 DILUTED SAMPLE RESULT OF < 3.0 G/ML VS. EXPECTED RESULT = 6.45 G/ML) FOR A SINGLE PROFICIENCY SAMPLE WHILE USING THE VITROS 5,1 FS CHEMISTRY SYSTEM. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THE EVENT WERE TO RECUR UNDETECTED WITH PATIENT SAMPLES. THERE WAS NO REPORT OF AFFECTED PATIENT SAMPLES. THERE WAS NO ALLEGATION OF HARM TO PATIENTS 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 5,1 FS CHEMISTRY SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1