BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 350 CHEMISTRY SYSTEM

    MDR report key: 8638530 · Received May 23, 2019

    Report

    Report Number
    1319681-2019-00044
    Event Type
    Malfunction
    Date Received
    May 23, 2019
    Date of Event
    March 3, 2019
    Report Date
    May 23, 2019
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT ONE HIGHER AND THREE LOWER THAN EXPECTED AMMONIA RESULTS WERE OBTAINED FROM ORTHO LIQUID PERFORMANCE VERIFIER (LPV) CONTROL FLUIDS WHEN TESTED USING VITROS AMMONIA (AMON) SLIDES ON A VITROS 350 CHEMISTRY SYSTEM. THE INVESTIGATION CONCLUDED THE MOST LIKELY ASSIGNABLE CAUSE IS INSTRUMENT RELATED, ASSOCIATED WITH MICROSLIDE INCUBATOR CONTAMINATION. AFTER CLEANING THE INCUBATOR EVAPORATION CAPS, ACCEPTABLE VITROS AMON PERFORMANCE WAS OBTAINED.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED ONE HIGHER AND THREE LOWER THAN EXPECTED AMMONIA RESULTS FROM ORTHO LIQUID PERFORMANCE VERIFIER (LPV) CONTROL FLUIDS WHEN TESTED USING VITROS AMMONIA (AMON) SLIDES ON A VITROS 350 CHEMISTRY SYSTEM. ORTHO LPV F6495 RESULT OF 93.4 UMOL/L WAS OBTAINED VERSUS AN EXPECTED RESULT OF 47.1 UMOL/L. ORTHO LPV G6496 RESULTS OF 150.3, 98.5 AND 71.6 UMOL/L WERE OBTAINED VERSUS AN EXPECTED RESULT OF 197.2 UMOL/L. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF UNDETECTED. THERE WAS NO REPORT OF AFFECTED PATIENT RESULTS AND THERE WAS NO ALLEGATION OF ACTUAL PATIENT HARM. HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS HAD NOT BEEN AFFECTED OR WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO).COMPLAINT NUMBERS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432453 VITROS 350 CHEMISTRY SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1