BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECI IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 2821695 · Received November 6, 2012

    Report

    Report Number
    1319681-2012-00216
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    September 8, 2012
    Report Date
    November 6, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KHO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT CODE 541-014 (LUMINOMETER DATA INVALID) OCCURRED ON MULTIPLE SAMPLES WHILE USING THE VITROS ANTI-HIV 1+2 REAGENT, LOT 2845 ON A VITROS ECI IMMUNODIAGNOSTIC ANALYZER. THE MOST LIKELY CAUSE IS A NON- REPORTABLE ASSAY ISSUE' HOWEVER, THIS COULD NOT BE CONFIRMED. THE OCCURRENCE OF THIS CODE MAY ALSO BE INDICATIVE OF AN INSTRUMENT RELATED ISSUE AND THESE ISSUES COULD NOT BE RULED OUT AT THE TIME OF THIS REPORT. INFORMATION REGARDING THE OPERATOR AND INITIAL REPORTER IS UNAVAILABLE AT THE TIME OF FILING OF THIS REPORT AND HENCE SECTION D AND E ARE INCOMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED INTERMITTENT 541-014 (LUMINOMETER DATA INVALID) CONDITION CODES THAT OCCURRED WITH MULTIPLE PATIENT WHEN TESTED ON A VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. THE CUSTOMER INDICATED THE CODES WERE OCCURRING ACROSS MULTIPLE SAMPLES BUT ONLY WHEN USING VITROS ANTI-HIV 1+2 REAGENT, LOT 2845. NO ERRONEOUS PATIENT SAMPLE RESULTS WERE REPORTED OUT OF THE LABORATORY AND THERE WERE NO ALLEGATIONS OF PATIENT HARM. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1