BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 4346605 · Received December 19, 2014

    Report

    Report Number
    1319681-2014-00197
    Event Type
    Malfunction
    Date Received
    December 19, 2014
    Date of Event
    October 16, 2014
    Report Date
    December 19, 2014
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED VITROS AMON RESULTS WERE OBTAINED FROM FIVE (5) CAP PROFICIENCY SAMPLES PROCESSED ON A VITROS 5600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THIS EVENT WAS USER ERROR DUE TO THE USE OF AMMONIA BASED CLEANERS NEAR THE SYSTEM WHICH RESULTED IN INCUBATOR CONTAMINATION. AN OCD FIELD ENGINEER (FE) PERFORMED AN INCUBATOR DECONTAMINATION PROCEDURE, INCLUDING CLEANING/REPLACING THE INCUBATOR EVAPORATION CAPS AND SLOTS, TO RETURN THE INSTRUMENT TO EXPECTED OPERATION. FOLLOWING THIS ACTIVITY, ACCEPTABLE VITROS AMON PERFORMANCE WAS OBSERVED.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED THAT HIGHER THAN EXPECTED VITROS AMON RESULTS WERE OBTAINED FROM FIVE (5) CAP PROFICIENCY SAMPLES PROCESSED ON A VITROS 5600 INTEGRATED SYSTEM. CAP CHM-11 VITROS AMON RESULTS 118, 118 VERSUS 97.1 UMOL/L; CAP CHM-12 VITROS AMON RESULT 302 VERSUS 245.1 UMOL/L; CAP CHM-13 VITROS AMON RESULT 205 VERSUS167.7 UMOL/L; CAP CHM-14 VITROS AMON RESULT 305 VERSUS 251.9 UMOL/L; CAP CHM-15 VITROS AMON RESULT 188 VERSUS 151.9 UMOL/L. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE CUSTOMER STATED THAT VITROS AMON PATIENT RESULTS WERE RELEASED FROM THE LABORATORY DURING THE TIME FRAME OF THE EVENT, BUT NO VITROS AMON PATIENT RESULTS HAVE BEEN QUESTIONED BY THE PHYSICIAN. HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WERE NOT AFFECTED OR WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837190 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1