BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 2971429 · Received February 21, 2013

    Report

    Report Number
    1319681-2013-00053
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 26, 2013
    Report Date
    February 21, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KHO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED, VITROS TROP I ES QUALITY CONTROL RESULT WAS OBTAINED FROM A KNOWN TROPONIN FREE SAMPLE PROCESSED ON THE VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. AN OCD FIELD ENGINEER PERFORMED SERVICE ACTIONS TO THE INCUBATOR SUBSYSTEM OF THE ANALYZER. PRECISION TESTING FOLLOWING SERVICE VERIFIED THAT THE EQUIPMENT WAS RETURNED TO EXPECTED OPERATION. THE MOST LIKELY ROOT CAUSE OF THIS EVENT IS ANALYZER RELATED.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A NON-REPRODUCIBLE, HIGHER THAN EXPECTED, VITROS TROP I ES RESULT FOR A KNOWN TROPONIN I FREE SAMPLE (0.070 VS. EXPECTED RESULTS < 0.014 NG/ML) PROCESSED ON THE VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF PATIENT SAMPLES WERE AFFECTED. THERE WAS NO INDICATION THAT PATIENT SAMPLES WERE AFFECTED AND 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
    75417 VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM IMMUNOASSAY SYSTEM KHO ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1