BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS PHYT SLIDES

    MDR report key: 2883101 · Received December 21, 2012

    Report

    Report Number
    1319809-2012-00299
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 16, 2012
    Report Date
    December 21, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DIP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT IMPRECISE VITROS PHYT QUALITY CONTROL RESULTS WERE OBTAINED ON A VITROS 5600 INTEGRATED SYSTEM. THERE IS NO EVIDENCE TO SUGGEST THAT AN INSTRUMENT RELATED ISSUE CONTRIBUTED TO THE EVENT. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. HOWEVER, THE MOST LIKELY ROOT CAUSE OF THIS EVENT WAS CONCLUDED AS REAGENT RELATED. EXPECTED PERFORMANCE WAS OBTAINED FOLLOWING CALIBRATION OF AN ALTERNATE LOT OF VITROS PHYT SLIDES.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED MULTIPLE IMPRECISE VITROS PHYT QUALITY CONTROL RESULTS (QC LOT Q2098= 32.81, 19.66, 20.46, 33.21 VS. AN EXPECTED RESULT= 26.80 NG/ML) ON A VITROS 5600 SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF PATIENT SAMPLES WERE AFFECTED. THERE WAS NO ALLEGATION THAT PATIENT SAMPLES WERE AFFECTED AND THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF FOUR MDR'S FOR THIS EVENT. FOUR 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 2610-0135-4025

    Patients

    Seq Age Sex Outcome Treatment
    1