BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 350 CHEMISTRY SYSTEM

    MDR report key: 3864108 · Received June 10, 2014

    Report

    Report Number
    1319681-2014-00106
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 12, 2014
    Report Date
    June 10, 2014
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT UNEXPECTED, NON-REPRODUCIBLE AMON QUALITY CONTROL RESULTS WERE OBTAINED WHILE USING THE VITROS 350 CHEMISTRY SYSTEM. THE MOST LIKELY ASSIGNABLE CAUSE OF THIS EVENT IS AN INSTRUMENT ISSUE RELATED TO MICROSLIDE INCUBATOR CONTAMINATION. THERE WAS NO EVIDENCE TO SUGGEST A MALFUNCTION OF THE VITROS AMON REAGENT LOT INVOLVED. FOLLOWING COMPLETION OF SERVICE ACTIONS TO THE INCUBATOR SUBSYSTEM OF THE VITROS 350 INSTRUMENT, ACCEPTABLE VITROS AMON PERFORMANCE WAS OBSERVED.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED UNEXPECTED, NON-REPRODUCIBLE AMMONIA RESULTS ON A SINGLE VITROS LIQUID PERFORMANCE VERIFIER (LPV) QUALITY CONTROL FLUID ON A VITROS 350 CHEMISTRY SYSTEM. LPV II QUALITY CONTROL RESULTS OF 136.0, 152.5, MOL/L VS. 195.0, MOL/L. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION, SHOULD THEY OCCUR UNDETECTED ON PATIENT SAMPLES. THE CUSTOMER STATED THAT NO VITROS AMON PATIENT RESULTS WERE PROCESSED DURING THE TIME FRAME OF THE EVENT. 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 PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338378 VITROS 350 CHEMISTRY SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1