BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5,1 FS CHEMISTRY SYSTEM

    MDR report key: 3920123 · Received July 8, 2014

    Report

    Report Number
    1319681-2014-00120
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    May 24, 2014
    Report Date
    July 8, 2014
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS AMON RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS BIORAD QUALITY CONTROL FLUID AND A SINGLE PATIENT SAMPLE TESTED ON A VITROS 5,1 FS CHEMISTRY SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT IS MOST LIKELY AN INSTRUMENT EVENT RELATED TO MICROSLIDE INCUBATOR CONTAMINATION. RESULTS OF PRECISION TESTING DEMONSTRATED THAT THE VITROS 5,1 FS CHEMISTRY SYSTEM WAS NOT OPERATING AS EXPECTED AT THE TIME OF THE EVENT. THE INVESTIGATION IS CURRENTLY ONGOING.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A LOWER THAN EXPECTED VITROS AMON PATIENT RESULT AND LOWER THAN EXPECTED QUALITY CONTROL RESULTS USING A VITROS 5,1 FS CHEMISTRY SYSTEM. BIORAD L3: 195.7, 184.2, 193.2, 190.7 UMOL/L VS. EXPECTED 245.0 UMOL/L.PATIENT: 87.4 UMOL/L VS. EXPECTED 133.3 UMOL/L.BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE AMON PATIENT RESULT OF 87.4 UMOL/L WAS PROCESSED FOR INVESTIGATIONAL PURPOSES ONLY AND WAS NOT REPORTED OUT OF THE LABORATORY. NO VITROS AMON PATIENT SAMPLE RESULTS WERE QUESTIONED. 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
    397329 VITROS 5,1 FS CHEMISTRY SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1