BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 950 CHEMISTRY SYSTEM

    MDR report key: 1981734 · Received February 8, 2011

    Report

    Report Number
    1319681-2011-00037
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 10, 2011
    Report Date
    February 8, 2011
    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 CONFIRMED THAT HIGHER THAN EXPECTED VITROS GLU CSF QUALITY CONTROL RESULTS WERE OBTAINED WHILE USING THE VITROS 950 ANALYZER. A DEFINITIVE ROOT CAUSE FOR THE EVENT COULD NOT BE DETERMINED, HOWEVER, AN INSTRUMENT RELATED ISSUE AND/OR THE QUALITY CONTROL FLUID IN USE CANNOT BE RULED OUT AS CONTRIBUTING FACTORS. THERE IS NO INDICATION THAT THE VITROS GLU SLIDE LOT IN USE OR VITROS 950 ANALYZER WERE NOT OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED HIGHER THAN EXPECTED VITROS GLU CSF QUALITY CONTROL RESULTS WHILE USING THE VITROS 950 CHEMISTRY SYSTEM. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THE EVENTS WERE TO RECUR WITH PATIENT SAMPLES. NO GLU PATIENT RESULTS WERE AFFECTED OR REPORTED FROM THE LABORATORY TO THE CLINICIAN. THERE WAS NO ALLEGATION OF HARM TO PATIENTS 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 950 CHEMISTRY SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1