BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 2181646 · Received July 27, 2011

    Report

    Report Number
    1319681-2011-00149
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 27, 2011
    Report Date
    July 27, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LFX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT DETERMINED THAT MULTIPLE, NON-REPRODUCIBLE VITROS ANTI-HBS (AHBS) AND RUBELLA IGG (RUB G) PATIENT RESULTS WERE OBTAINED. AN OCD FIELD ENGINEER PERFORMED "AS NEEDED" SERVICE TO THE REAGENT METERING AND WELL WASH SUBSYSTEMS ON THE VITROS ECIQ ANALYZER. PERFORMANCE TESTING FOLLOWING SERVICE VERIFIED THAT THE EQUIPMENT WAS RETURNED TO EXPECTED OPERATION. THE ASSIGNABLE ROOT CAUSE WAS AN INSTRUMENT RELATED ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED MULTIPLE NON-REPRODUCIBLE VITROS ANTI-HBS (AHBS) AND RUBELLA IGG (RUB G) PATIENT RESULTS WHILE USING THE VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. VITROS AHBS RESULTS FOR A SINGLE PATIENT SAMPLE GAVE THE FOLLOWING RESULTS: (B)(6). VITROS RUBELLA RESULTS FOR FIVE PATIENT SAMPLES WERE AFFECTED: PATIENT 1 RUB G RESULT OF 6.45 IU/ML (NEGATIVE) VS. 219 & 162 IU/ML (POSITIVE). PATIENT 2 RUB G RESULT OF 6.98 IU/ML (NEGATIVE) VS. 99.6 IU/ML (POSITIVE). PATIENT 3 RUB G RESULT OF 22.9 IU/ML (POSITIVE) VS. 8.29 IU/ML (NEGATIVE). PATIENT 4 RUB G RESULT OF 9.71 IU/ML (NEGATIVE) VS. 93.0 IU/ML (POSITIVE). PATIENT 5 RUB G RESULT OF 2.3 IU/ML (NEGATIVE) VS. 34.1 & 26.8 IU/ML (POSITIVE). BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION. NO AFFECTED PATIENT RESULTS WERE REPORTED TO CLINICIAN. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1