BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5, 1 FS CHEMISTRY SYSTEM

    MDR report key: 1511732 · Received October 5, 2009

    Report

    Report Number
    1319681-2009-00306
    Event Type
    Malfunction
    Date Received
    October 5, 2009
    Date of Event
    September 5, 2009
    Report Date
    September 6, 2009
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IDENTIFIED AN ISSUE WITH THE IMMUNOWASH FLUID (IWF) METERING SYSTEM. THE CUSTOMER WAS DIRECTED TO PERFORM ROUTINE MAINTENANCE PROCEDURE INVOLVING THE IWF METERING TIP, FLUID, AND SUBSYSTEM TUBING. ACCEPTABLE PHYT PERFORMANCE WAS OBTAINED FOLLOWING THE MAINTENANCE ACTIVITY. THE ROOT CAUSE OF THE POSITIVELY BIASED QUALITY CONTROL FLUID RESULTS IS INSTRUMENT RELATED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED POSITIVELY BIASED QUALITY CONTROL RESULTS PROCESSED USING VITROS PHYT SLIDES ON A VITROS 5.1 FS CHEMISTRY SYSTEM ON (B)(6) AND (B)(6), 2009. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE CUSTOMER DID NOT PROCESS PT SAMPLES WHILE QUALITY CONTROL WAS UNACCEPTABLE. THERE WAS NO REPORT OF PT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1