BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5,1 FS CHEMISTRY SYSTEM

    MDR report key: 3030356 · Received April 2, 2013

    Report

    Report Number
    1319681-2013-00077
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    February 27, 2013
    Report Date
    April 2, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT MULTIPLE, NON-REPRODUCIBLE, HIGHER THAN EXPECTED, VITROS AMON PATIENT RESULTS WERE OBTAINED ON A VITROS 5600 INTEGRATED SYSTEM. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY ROOT CAUSE OF THE EVENT IS ANALYZER RELATED DUE TO INCUBATOR CONTAMINATION. ACCEPTABLE AMON PERFORMANCE WAS OBTAINED AFTER PERFORMING THE ROUTINE MAINTENANCE PROCEDURE OF REPLACING THE RATE/CM MICROSLIDE EVAPORATION CAP.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED MULTIPLE, NON-REPRODUCIBLE, HIGHER THAN EXPECTED, VITROS AMON PATIENT RESULTS ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT 1 = 116 VS. AN EXPECTED RESULT = 45 MMOL/L; PATIENT 2 = 94 VS. AN EXPECTED RESULT = 55.5 MMOL/L; BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. HOWEVER, THE AFFECTED RESULTS WERE NOT REPORTED AS THE CUSTOMER BELIEVED THE REPRODUCIBLE PATIENT RESULTS TO BE TRUE AND WERE REPORTED OUT OF THE LABORATORY. 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
    134619 VITROS 5,1 FS CHEMISTRY SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1