BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 8186676 · Received December 20, 2018

    Report

    Report Number
    1319681-2018-00129
    Event Type
    Malfunction
    Date Received
    December 20, 2018
    Date of Event
    October 19, 2018
    Report Date
    December 20, 2018
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A LOWER THAN EXPECTED VITROS PHENYTOIN (PHYT) RESULT WAS OBTAINED FOR ONE PROFICIENCY SAMPLE TESTED ON A VITROS 5600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THIS EVENT IS USER ERROR DUE TO INAPPROPRIATE INTERPRETATION OF AN ANALYZER CONDITION CODE. AN ANALYZER CONDITION CODE U90-382 (IR WASH ERROR) OCCURRED WHEN THE SAMPLE WAS INITIALLY RUN, AND NO PHYT RESULT WAS GENERATED AT THAT TIME. THE CONDITION CODE INSTRUCTED THE OPERATOR TO PROGRAM THE SAMPLE FOR REPEAT PHYT TESTING WITH DILUTION TO CONFIRM IF THE RESULT IS GREATER THAN THE ASSAY MEASURING RANGE. THE LABORATORY PERFORMED TWO DILUTIONS OF THE CAP SAMPLE AND THE RESULTS OBTAINED WERE LESS THAN THE PHYT MEASURING RANGE. THE LAB REPORTED A PHYT RESULT EQUAL TO THE LOW END OF THE PHYT MEASURING RANGE (3.0 UG/ML) IN ERROR AS THEY INTENDED TO REPORT A <3.0 UG/ML. HOWEVER, IT WAS NOT APPROPRIATE FOR THE USER TO REPORT THE PHYT RESULT OBTAINED FROM THE DILUTION BECAUSE THE PHYT CONCENTRATION IN THAT SAMPLE DID NOT EXCEED THE MEASURING RANGE. THERE WAS NO EVIDENCE TO SUGGEST A MALFUNCTION OF THE VITROS 5600 INTEGRATED SYSTEM OR THE PHYT SLIDE LOT.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED A LOWER THAN EXPECTED VITROS PHENYTOIN (PHYT) RESULT FOR ONE PROFICIENCY SAMPLE TESTED ON A VITROS 5600 INTEGRATED SYSTEM. COLLEGE OF AMERICAN PATHOLOGISTS (CAP) PROFICIENCY FLUID (CHM-13) VITROS PHYT RESULT OF 3.0 UG/ML VERSUS EXPECTED 5.69 UG/ML BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THE ISSUE WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE LOWER THAN EXPECTED VITROS PHYT RESULT WAS OBTAINED WHEN PROCESSING A PROFICIENCY FLUID. HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WAS NO ALLEGATION OF ACTUAL PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO).COMPLAINT NUMBERS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1023492 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1