BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5,1 FS CHEMISTRY SYSTEM

    MDR report key: 3191315 · Received June 26, 2013

    Report

    Report Number
    1319681-2013-00131
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 24, 2013
    Report Date
    June 26, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A NON-REPRODUCIBLE, LOWER THAN EXPECTED, VITROS AMON QUALITY CONTROL RESULT WAS OBTAINED FROM A VITROS LPVII FLUID ON A VITROS 5,1 FS CHEMISTRY SYSTEM. THE CUSTOMER PERFORMED ROUTINE MAINTENANCE PROCEDURE OF CLEANING THE MICROSLIDE INCUBATOR EVAPORATION CAPS. ACCEPTABLE AMON PERFORMANCE WAS OBTAINED FOLLOWING THESE SERVICE ACTIONS. THE ROOT CAUSE OF THE EVENT IS MOST LIKELY ANALYZER RELATED. ADDITIONALLY, USER ERROR FOR THE OBSERVED INCUBATOR CONTAMINATION CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR. THERE WAS NO EVIDENCE THAT A REAGENT RELATED ISSUE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A NON-REPRODUCIBLE, LOWER THAN EXPECTED, VITROS AMON QUALITY CONTROL RESULT (136.2 VS. AN EXPECTED RESULT = 171.0 MOL/L) FROM A VITROS LPV II FLUID ON A VITROS 5,1 FS CHEMISTRY SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. NO PATIENT SAMPLES RUN DURING THE TIME FRAME OF THE EVENT. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291201 VITROS 5,1 FS CHEMISTRY SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1