BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 250 CHEMISTRY SYSTEM

    MDR report key: 938063 · Received April 13, 2007

    Report

    Report Number
    1319681-2007-00089
    Event Type
    Malfunction
    Date Received
    April 13, 2007
    Date of Event
    March 18, 2007
    Report Date
    March 18, 2007
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: INVESTIGATION INTO THIS EVENT DETERMINED THAT THE CUSTOMER WAS NOT ADEQUATELY CLEANING THE TIP LOCATOR WHILE PERFORMING ROUTINE MAINTENANCE, ALLOWING SALT BUILD-UP IN THE REFERENCE METERING PORT. THE FIELD ENGINEER CLEANED THE BUILD-UP AND PERFORMED RELATED ADJUSTMENTS. QC RESULTS FOLLOWING SERVICE WERE ACCEPTABLE. THE ROOT CAUSE OF THIS EVENT IS USER ERROR.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED POSITIVELY BIASED K+ QC RESULTS ON THE 250 ANALYZER. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. NO PATIENT SAMPLE WERE BEING TESTED, AND THERE WAS NO REPORT OF PT HARM AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS 250 CHEMISTRY SYSTEM CLINICAL CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *