BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 250 CHEMISTRY SYSTEM

    MDR report key: 3170794 · Received June 14, 2013

    Report

    Report Number
    1319681-2013-00126
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 8, 2013
    Report Date
    June 14, 2013
    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 MULTIPLE, UNEXPECTED, VITROS AMON QUALITY CONTROL RESULTS WERE OBTAINED FROM A VITROS LPVII FLUID ON A VITROS 250 CHEMISTRY SYSTEM. AN OCD FE PERFORMED SERVICE ACTIONS TO RETURN THE VITROS 250 INSTRUMENT TO EXPECTED PERFORMANCE. THE ROOT CAUSE OF THE EVENT IS MOST LIKELY ANALYZER EVENT. THERE WAS NO EVIDENCE THAT A REAGENT RELATED ISSUE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED MULTIPLE, UNEXPECTED, VITROS AMON QUALITY CONTROL RESULTS FROM A VITROS LPVII FLUID ON A VITROS 250 CHEMISTRY SYSTEM. QC FLUID LEVEL 2 = 233.4, 232.1, 217.3, 358.6 VS. AN EXPECTED RESULT = 295.5 UG/DL; BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. NO PATIENT SAMPLES WERE RUN OR WERE AFFECTED. 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
    270683 VITROS 250 CHEMISTRY SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1