BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS PHYT SLIDES

    MDR report key: 3904623 · Received July 1, 2014

    Report

    Report Number
    1319809-2014-00026
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    June 2, 2014
    Report Date
    July 1, 2014
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DIP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT UNEXPECTED VITROS PHYT RESULTS WERE OBTAINED FROM TWO DIFFERENT SAMPLES COLLECTED FROM THE SAME PATIENT PROCESSED ON TWO DIFFERENT VITROS 5600 INTEGRATED SYSTEMS. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ASSIGNABLE CAUSE, HOWEVER; AS THE EVENT WAS ISOLATED TO SAMPLES COLLECTED FROM THE SAME PATIENT, A SAMPLE RELATED ISSUE ASSOCIATED WITH THE AFFECTED PATIENT CANNOT BE RULED OUT AS A POTENTIAL CONTRIBUTING FACTOR. THERE WAS NO INDICATION THE VITROS PHYT SLIDE LOT OR THE VITROS 5600 INTEGRATED SYSTEMS MALFUNCTIONED. A DEFINITIVE ROOT CAUSE FOR THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED UNEXPECTED VITROS PHENYTOIN (PHYT) RESULTS PREDICTED FROM TWO DIFFERENT SAMPLES COLLECTED FROM THE SAME PATIENT PROCESSED ON TWO DIFFERENT VITROS 5600 INTEGRATED SYSTEMS. SAMPLE 1: 12.49, 12.84, 12.40, 13.62, 9.08 AND 4.82 UG/ML VS. 25.0 UG/ML. SAMPLE 2: 18.06 AND 17.57 UG/ML. VS. 25.0 UG/ML. BIASED PATIENT RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. NONE OF THE UNEXPECTED VITROS PHYT RESULTS FOR EITHER SAMPLE WERE REPORTED FROM THE LABORATORY AND THERE WAS NO ALLEGATION OF PATIENT HARM. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382548 VITROS CHEMISTRY PRODUCTS PHYT SLIDES IN-VITRO DIAGNOSTIC DIP ORTHO-CLINICAL DIAGNOSTICS 2613-0146-0550

    Patients

    Seq Age Sex Outcome Treatment
    1