BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5, 1 FS CHEMISTRY SYSTEM

    MDR report key: 956038 · Received April 25, 2007

    Report

    Report Number
    1319681-2007-00101
    Event Type
    Malfunction
    Date Received
    April 25, 2007
    Date of Event
    March 28, 2007
    Report Date
    March 28, 2007
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: INVESTIGATION INTO THIS EVENT FOUND THAT DURING THE TIME OF BIASED QC RESULTS THE INSTRUMENT DID NOT DISPLAY ANY CONDITIONS CODES. THE CUSTOMER WAS USING PROPER REAGENT HANDLING TECHNIQUES. DURING SERVICE THE INSTRUMENT POSTED CONDITION CODES ASSOCIATED WITH SECONDARY METERING. ADJUSTMENTS WERE MADE TO THE METERING SYSTEM AND SUBSEQUENT QC RESULTS WERE AS EXPECTED. THE ROOT CAUSE OF THE BIASED RESULTS IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED POSITIVELY BIASED QC RESULTS WHILE TESTING VALP ON THE 5, 1 FS ANALYZER. 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, 1 FS CHEMISTRY SYSTEM CLINICAL CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *