BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5,1 FS CHEMISTRY SYSTEM

    MDR report key: 965239 · Received December 17, 2007

    Report

    Report Number
    1319681-2007-00381
    Event Type
    Malfunction
    Date Received
    December 17, 2007
    Date of Event
    November 1, 2007
    Report Date
    November 26, 2007
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER SAW IMPRECISE VITROS AMON RESULTS ON QC SAMPLES. OCD FIELD SERVICE EVALUATED THE VITROS 5,1 FS ANALYZER AND FOUND DAMAGED/WORN INCUBATOR CLIPS IN THE INCUBATOR USED TO PROCESS AMON. THE FIELD ENGINEER REPLACED THE INCUBATOR CAPS AND CLEANED THE INCUBATOR. PRECISION TESTING, POST SERVICE, WAS WITHIN SPECIFICATIONS. OCD FIELD SERVICE PERFORMED REPAIRS TO RETURN DEVICE TO EXPECTED OPERATION. THE ROOT CAUSE WAS DETERMINED TO BE INCUBATOR CONTAMINATION CAUSED BY DAMAGED AND WORN INCUBATOR CLIPS. FIELD SERVICE OF THE DEVICE HAS RESOLVED THE ISSUE. NO PATIENT RESULTS WERE MISREPORTED AND NO PATIENT HARM HAS BEEN ALLEGED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    AN OCD CUSTOMER OBSERVED IMPRECISE QUALITY CONTROL RESULTS FOR THE VITROS AMON ASSAY ON A VITROS 5,1 FS ANALYZER. THE CUSTOMER OBSERVED THE IMPRECISE RESULTS ON 1 NOV 2007, 10 NOV 2007, 19 NOV 2007, AND 20 NOV 2007. THE CUSTOMER DID NOT REPORT THE EVENT TO OCD UNTIL 26 NOV 2007. THERE WAS NO ALLEGATION OF MISREPORTED PATIENT RESULTS AND NO ALLEGATION OF HARM TO ANY PATIENTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR