BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5, 1FS CHEMISTRY SYSTEM

    MDR report key: 836107 · Received March 23, 2007

    Report

    Report Number
    1319681-2007-00067
    Event Type
    Malfunction
    Date Received
    March 23, 2007
    Date of Event
    February 20, 2007
    Report Date
    February 24, 2007
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: INVESTIGATION INTO THIS EVENT SHOWED THAT THE CUSTOMER WAS PERFORMING AN INTERNAL DILUTION STUDY, AND WAS DILUTING SAMPLES WITHIN THE REPORTABLE RANGE USING IRRIGATION WATER RATHER THAN REAGENT GRADE WATER. THEY WERE ALSO PERFORMING DILUTIONS GREATER THAN THE RECOMMENDED DILUTION. THE CUSTOMER IS NOT FOLLOWING OCD RECOMMENDED PROCEDURES FOR SAMPLE DILUTION. USE ERROR WAS THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED NEGATIVELY BIASED AMON RESULTS FOR DILUTED SAMPLES ON THE 5, 1 FS ANALYZER. NO BIASED RESULTS WERE REPORTED. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *