BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS PHYT SLIDES

    MDR report key: 1203385 · Received October 10, 2008

    Report

    Report Number
    1319809-2008-00305
    Event Type
    Malfunction
    Date Received
    October 10, 2008
    Date of Event
    September 11, 2008
    Report Date
    September 11, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DIP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS CONFIRMED THAT LOWER THEN EXPECTED RESULTS WERE OBTAINED ON VITROS PHYT SLIDES WITH SAMPLES OBTAINED FROM ONE REMOTE SITE. ADDITIONAL SAMPLES FROM ALTERNATE SITES DID NOT SHOW PHYT BIAS DURING THIS EVENT. ADDITIONAL SAMPLES WERE REQUESTED FROM THE SITE IN QUESTION AND DID NOT EXHIBIT ANY BIAS. QUALITY CONTROL RESULTS WERE WITHIN EXPECTED VALUES AT ALL TIMES DURING THIS EVENT. NO INSTRUMENT MECHANICAL OR ANALYTICAL ERRORS WERE SEEN DURING THIS EVENT. ADDITIONAL INVESTIGATIVE TESTING DONE TO ASSESS INSTRUMENT PERFORMANCE WAS WITHIN EXPECTED RESULTS. NO ROOT CAUSE WAS DETERMINED FOR THIS EVENT BUT IT MOST LIKELY SAMPLE RELATED.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED NEGATIVELY BIASED PHYT PT RESULTS ON A VITROS 5, 1 FS ANALYZER. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED ON A PT SPECIMEN MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. NO PT SAMPLES IN QUESTION WERE REPORTED DURING THE TIME OF THIS EVENT. THERE WAS NO REPORT OF PT HARM AS A RESULT OF THIS EVENT.

    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 2636-0095-0696

    Patients

    Seq Age Sex Outcome Treatment
    1