BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 250 CHEMISTRY SYSTEM

    MDR report key: 4093726 · Received September 16, 2014

    Report

    Report Number
    1319681-2014-00145
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 7, 2014
    Report Date
    September 16, 2014
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT HIGHER THAN EXPECTED VITROS AMON RESULTS WERE OBTAINED FROM TWO DIFFERENT LEVELS OF NON-VITROS BIORAD QUALITY CONTROL FLUIDS TESTED ON A VITROS 250 CHEMISTRY SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT IS MOST LIKELY AN INSTRUMENT EVENT RELATED TO MICROSLIDE INCUBATOR CONTAMINATION. THE CAUSE OF THE AMON CONTAMINATION OF THE MICROSLIDE INCUBATOR WAS NOT IDENTIFIED. RESULTS OF PRECISION TESTING DEMONSTRATED THAT THE VITROS 250 CHEMISTRY SYSTEM WAS NOT OPERATING AS EXPECTED AT THE TIME OF THE EVENT. FOLLOWING SERVICE ACTIONS AND RECALIBRATION OF THE ASSAY, ACCEPTABLE VITROS AMON PERFORMANCE WAS OBTAINED.

    Description of Event or Problem · 1

    THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED VITROS AMON RESULTS WERE OBTAINED FROM TWO DIFFERENT LEVELS OF NON-VITROS BIORAD QUALITY CONTROL FLUIDS TESTED ON A VITROS 250 CHEMISTRY SYSTEM. BIORAD L2: RESULTS OF 103, 105, 99, 106, 106, 104, 127.4, 130.0, 129.7, 127.0, 128.8, 130.4, 131.5, 132.3, 129.4, 129.5, 129.2, 123.8, 129.8, 134.9, 131.2, 130.6, 128.5, 132.2, 126.8, 128.0, 131.9, 135.4, 129.4, 133.3, 130.4, 131.0, 130.8, 127.6, 128.0, 131.0, 131.5, 130.3, 130.8, 132.5, 128.6, 127.3, 127.4, 130.9, 130.1, 128.6, 129.8, 130.8, 131.6, 129.0, 127.6, 126.5, 130.9, 129.2, 132, 131, 132, 131, 131, 133, 132, 129, 131, 135, 132, 130, 129, 133, 131, 127, 132, 132, 132, 129, 130, 133, 127, 130 UMOL/L COMPARED TO AN EXPECTED RESULT OF 81.5 UMOL/L. BIORAD L3: RESULTS OF 276, 254, 291, 251, 281, 270, 283, 240, 250, 272, 268, 253, 300, 245 AND 301 UMOL/L COMPARED TO AN EXPECTED RESULT OF 197.0 UMOL/L. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION, SHOULD THEY OCCUR UNDETECTED ON PATIENT SAMPLES. PATIENT SAMPLES WERE PROCESSED WITH THE VITROS AMON ASSAY OVER THE TIME FRAME OF THE EVENT; THOUGH NO REPORTED PATIENT RESULTS HAD BEEN IN QUESTION. THERE WAS NO REPORTED ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573533 VITROS 250 CHEMISTRY SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1