BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS AMON REAGENT

    MDR report key: 3809753 · Received May 14, 2014

    Report

    Report Number
    1319809-2014-00022
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    April 15, 2014
    Report Date
    May 14, 2014
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JID
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS AMON RESULTS WERE OBTAINED FROM TWO DIFFERENT PATIENT SAMPLES USING VITROS CHEMISTRY PRODUCTS AMON MICROSLIDES ON A VITROS 5,1 FS CHEMISTRY SYSTEM, WHEN COMPARED TO RESULTS OBTAINED FROM THE SAME SAMPLES PROCESSED USING VITROS AMON SLIDES ON A VITROS 350 CHEMISTRY SYSTEM. THE ASSIGNABLE CAUSE OF THE INVESTIGATION IS UNKNOWN. HOWEVER, AN INSTRUMENT ISSUE WITH THE VITROS 5,1 FS CHEMISTRY SYSTEM OR A REAGENT ISSUE WITH VITROS AMON LOT IN USE AT THE TIME OF THE EVENT CANNOT BE RULED OUT AS POTENTIAL CONTRIBUTING FACTORS. A FIXED BIAS IN VITROS AMON ACCURACY WAS OBSERVED BETWEEN THE TWO INSTRUMENTS AT THE TIME OF THE EVENT, WHICH IS CONSIDERED A CONTRIBUTING FACTOR FOR THE OVERALL BIASES OBSERVED. HOWEVER, NON-REPRODUCIBLE VITROS AMON PERFORMANCE ALSO CONTRIBUTED TO THE MAGNITUDE OF BIAS OBSERVED AS RESULTS OF PRECISION TESTING DEMONSTRATED ATYPICAL WITHIN-RUN PERFORMANCE ON THE VITROS 5,1 FS CHEMISTRY SYSTEM. SERVICE ACTIONS WERE COMPLETE, HOWEVER VITROS AMON WITHIN-RUN PERFORMANCE REMAINED ATYPICAL ON THE VITROS 5,1 FS CHEMISTRY SYSTEM. AN ALTERNATE VITROS AMON REAGENT LOT WAS PUT INTO USE, AND ACCEPTABLE WITHIN-RUN PERFORMANCE WAS ACHIEVED WITHOUT ANY ADDITIONAL CHANGES TO THE INSTRUMENT.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED LOWER THAN EXPECTED RESULTS FROM TWO DIFFERENT PATIENT SAMPLES USING VITROS AMON MICROSLIDES ON A VITROS 5,1 FS CHEMISTRY SYSTEM , COMPARED TO RESULTS OBTAINED FROM THE SAME SAMPLES PROCESSED USING VITROS AMON SLIDES ON A VITROS 350 CHEMISTRY SYSTEM. PATIENT SAMPLE 3: 455.0 UMOL/L VS. THE EXPECTED RESULT OF 572.2 UMOL/L. PATIENT SAMPLE 11: 130.1 UMOL/L VS. THE EXPECTED RESULT OF 166.8 UMOL/L. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE LOWER THAN EXPECTED RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY AND THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF TWO 3500A FORMS FILED FOR THIS EVENT, AS TWO DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288829 VITROS CHEMISTRY PRODUCTS AMON REAGENT IN-VITRO DIAGNOSTIC JID ORTHO-CLINICAL DIAGNOSTICS 1014-0231-4336

    Patients

    Seq Age Sex Outcome Treatment
    1