BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECI IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 2883712 · Received December 21, 2012

    Report

    Report Number
    1319681-2012-00255
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 28, 2012
    Report Date
    December 21, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KHO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT CODE 541-014 (LUMINOMETER DATA INVALID) OCCURRED ON MULTIPLE PATIENT AND QUALITY CONTROL SAMPLES WHILE USING THE VITROS AHCVREAGENT, LOT 3080 ON A VITROS ECI IMMUNODIAGNOSTIC ANALYZER. ROOT CAUSE FOR THE 541-014 CODES IS LIKLEY TO BE RELATED TO LOW SIGNAL PRODUCING PATIENT SAMPLES (SIGNAL BELOW THE VITROS AHCV ASSAY'S MINIMUM THRESHOLD). HOWEVER, AN INSTRUMENT RELATED ISSUE CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED INTERMITTENT 541-014 (LUMINOMETER DATA INVALID) CONDITION CODES THAT OCCURRED WITH MULTIPLE PATIENT AND QUALITY CONTROL SAMPLES WHEN TESTED ON A VITROS ECI IMMUNODIAGNOSTIC SYSTEM. THE CUSTOMER INDICATED THE CODES WERE OCCURRING ACROSS MULTIPLE SAMPLES BUT ONLY WHEN USING VITROS AHCV, LOT 3080. NO ERRONEOUS PATIENT SAMPLE RESULTS WERE REPORTED OUT OF THE LABORATORY AND THERE WERE NO ALLEGATIONS OF PATIENT HARM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS ECI IMMUNODIAGNOSTIC SYSTEM IMMUNODIAGNOSTIC ANALYZER KHO ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1