BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 350 CHEMISTRY SYSTEM

    MDR report key: 2863816 · Received December 10, 2012

    Report

    Report Number
    1319681-2012-00237
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 8, 2012
    Report Date
    December 7, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED VITROS AMON RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE ON A VITROS 350 SYSTEM. THERE WAS NO EVIDENCE THAT A REAGENT ISSUE CONTRIBUTED TO THE EVENT. AN OCD LABORATORY SPECIALIST PERFORMED "AS-REQUIRED" MAINTENANCE ACTIVITIES TO THE MICROSLIDE INCUBATOR SUBSYSTEM OF THE ANALYZER. FOLLOWING THESE ACTIVITIES, THE ANALYZER WAS RETURNED TO EXPECTED PERFORMANCE. THE MOST LIKELY ROOT CAUSE OF THIS EVENT IS AN INSTRUMENT RELATED ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED IMPRECISE VITROS AMON RESULTS (PATIENT RESULTS=180 VS. 107, 114 UG/DL) FROM A SINGLE PATIENT SAMPLE ON A VITROS 350 SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. HOWEVER, NO VITROS AMON PATIENT SAMPLE RESULTS WERE REPORTED OUT OF THE LABORATORY AT THE TIME OF THE EVENT. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1