BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS PHYT SLIDES

    MDR report key: 4061320 · Received September 4, 2014

    Report

    Report Number
    1319809-2014-00042
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    June 16, 2014
    Report Date
    September 4, 2014
    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 A HIGHER THAN EXPECTED VITROS PHYT RESULT WAS OBTAINED FOR A PROFICIENCY FLUID WHILE USING THE VITROS 250 CHEMISTRY SYSTEM. THE INVESTIGATION FOUND NO EVIDENCE OF AN INSTRUMENT OR REAGENT MALFUNCTION, HOWEVER NEITHER CAN BE COMPLETELY RULED OUT AS POTENTIAL CONTRIBUTING FACTORS. ADDITIONALLY, A SAMPLE RELATED ISSUE CANNOT BE ELIMINATED AS A POTENTIAL CONTRIBUTING FACTOR.THE ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED A HIGHER THAN EXPECTED VITROS PHYT RESULT FOR A PROFICIENCY FLUID WHILE USING THE VITROS 250 CHEMISTRY SYSTEM. CHM-08: 53.8 UMOL/L VERSUS EXPECTED 42.0 UMOL/L. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF PATIENT SAMPLES WERE AFFECTED. THE CUSTOMER MADE NO ALLEGATIONS THAT PATIENT SAMPLE RESULTS WERE AFFECTED. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT.(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540969 VITROS CHEMISTRY PRODUCTS PHYT SLIDES IN-VITRO DIAGNOSTIC DIP ORTHO-CLINICAL DIAGNOSTICS 2613-0146-1449

    Patients

    Seq Age Sex Outcome Treatment
    1