BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5,1 FS CHEMISTRY SYSTEM

    MDR report key: 2930190 · Received January 25, 2013

    Report

    Report Number
    1319681-2013-00037
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    December 28, 2012
    Report Date
    January 25, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT MULTIPLE UNEXPECTED VITROS AMON QUALITY CONTROL RESULTS WERE OBTAINED ON A VITROS 5,1 FS CHEMISTRY SYSTEM. THERE WAS NO EVIDENCE THAT A REAGENT ISSUE CONTRIBUTED TO THE EVENT. SERVICE ACTIONS WERE PERFORMED TO RETURN THE VITROS 5,1 FS CHEMISTRY SYSTEM 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 MULTIPLE UNEXPECTED VITROS AMON QUALITY CONTROL RESULTS (QC LPVII D1731= 145.6, 109.5, 232.4 VS. EXPECTED RESULT= 185.7 MMOL/L) ON A VITROS 5,1 FS CHEMISTRY SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. 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. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35582 VITROS 5,1 FS CHEMISTRY SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1