BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS PHYT SLIDES

    MDR report key: 1901219 · Received November 17, 2010

    Report

    Report Number
    1319809-2010-00060
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    October 13, 2010
    Report Date
    November 17, 2010
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DIP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT IMPRECISE AND LOWER THAN EXPECTED PHYT QUALITY CONTROL RESULTS WERE OBTAINED FROM THE VITROS 5,1 FS CHEMISTRY SYSTEM. THE INVESTIGATION FOUND NO EVIDENCE TO SUGGEST THE RESULTS IN QUESTION WERE CAUSED BY AN ANALYZER MALFUNCTION. AN ALTERNATE PHYT SLIDE LOT HAS RESOLVED THE ISSUE. THE FDA'S NEW YORK DISTRICT OFFICE WAS NOTIFIED OF THIS ISSUE ON (B)(6) 2010. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY ROOT CAUSE IS REAGENT RELATED. INVESTIGATION OF PHYT REAGENT LOTS 2649-0115-XXXX IS ONGOING.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED IMPRECISE AND LOWER THAN EXPECTED VITROS PHYT QUALITY CONTROL RESULTS WHILE USING THE VITROS 5,1 FS CHEMISTRY SYSTEM. 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. THIS REPORT IS NUMBER ONE OF TWO MDR'S FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FOUR DEVICES WERE INVOLVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS CHEMISTRY PRODUCTS PHYT SLIDES IN-VITRO DIAGNOSTIC DIP ORTHO-CLINICAL DIAGNOSTICS 2649-0115-0145

    Patients

    Seq Age Sex Outcome Treatment
    1