BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS PHYT SLIDES

    MDR report key: 3132896 · Received May 29, 2013

    Report

    Report Number
    1319809-2013-00135
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 29, 2013
    Report Date
    May 28, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DIP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT MULTIPLE, DISCORDANT, NON-REPRODUCIBLE, AND UNEXPECTED; VITROS PHYT RESULTS WERE OBTAINED FROM TWO DIFFERENT PATIENT SAMPLES AND A PROFICIENCY SAMPLE WHILE PERFORMING A CORRELATION STUDY USING A VITROS 250 CHEMISTRY SYSTEM. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE FOR THE AFFECTED PATIENT SAMPLES. ACCEPTABLE PERFORMANCE WAS VERIFIED FOR THE CURRENT VITROS PHYT LOT 2609-0137-1657 IN USE. THE INVESTIGATION SUSPECTS PRE-ANALYTICAL SAMPLE MIX UP MAY HAVE CONTRIBUTED TO THE DISCORDANT RESULT OBTAINED FROM THE PROFICIENCY FLUID, HOWEVER, THIS CANNOT BE CONFIRMED. THERE WAS NO EVIDENCE THAT AN INSTRUMENT OR REAGENT RELATED ISSUE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED MULTIPLE, DISCORDANT, NON-REPRODUCIBLE, AND UNEXPECTED, VITROS PHYT RESULTS FROM TWO DIFFERENT PATIENT SAMPLES AND A PROFICIENCY SAMPLE WHILE PERFORMING A CORRELATION STUDY USING A VITROS 250 CHEMISTRY SYSTEM. THE FOLLOWING RESULTS WERE OBTAINED: PATIENT 1 = 29.0 VS. AN EXPECTED RESULT = 15.0 MMOL/L; PATIENT 2 = 75.0 VS. AN EXPECTED RESULT = 59.5 MMOL/L; PROFICIENCY SAMPLE = 138.0 VS. AN EXPECTED RESULT = 113.5 MMOL/L; BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. NO PATIENT SAMPLES RUN DURING THE TIME FRAME OF THE EVENT WERE QUESTIONED. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER THREE OF THREE MDR¿S FOR THIS EVENT. THREE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS THREE DEVICES WERE INVOLVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236364 VITROS CHEMISTRY PRODUCTS PHYT SLIDES IN-VITRO DIAGNOSTIC DIP ORTHO-CLINICAL DIAGNOSTICS 2609-0137-0885

    Patients

    Seq Age Sex Outcome Treatment
    1