BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS PHYT SLIDES

    MDR report key: 928293 · Received October 17, 2007

    Report

    Report Number
    1319809-2007-00310
    Event Type
    Malfunction
    Date Received
    October 17, 2007
    Date of Event
    September 17, 2007
    Report Date
    September 18, 2007
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DIP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT FOUND THAT THE PRECISION OF THE SYSTEM WITH THIS ASSAY DID NOT PERFORM AS EXPECTED. AN OCD FIELD ENGINEER VERIFIED THAT THE ANALYZER WAS OPERATING WITHIN EXPECTED TOLERANCES. IT WAS DETERMINED THAT THE OPERATOR STORED THE PRODUCT IN A FREEZER WHICH COULD EXCEED THE STORAGE CONDITIONS INDICATED IN THE ASSAY INSTRUCTIONS FOR USE. AN ALTERNATE SLIDE LOT PERFORMED WITHIN EXPECTATIONS. THE MOST LIKELY ROOT CAUSE OF THE IMPRECISE RESULTS IS USER ERROR.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED IMPRECISE VITROS PHYT SLIDE QC FLUID RESULTS ON THE VITROS 350 ANALYZER. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THERE WERE NO PATIENT RESULTS REPORTED AND THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTH CLINICAL DIAGNOSTICS INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS CHEMISTRY PRODUCTS PHYT SLIDES IN VITRO DIAGNOSTIC DIP ORTHO-CLINICAL DIAGNOSTICS NA 2632-0087-6040

    Patients

    Seq Age Sex Outcome Treatment
    1 YR