BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 2970114 · Received February 20, 2013

    Report

    Report Number
    1319681-2013-00051
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    January 22, 2013
    Report Date
    February 20, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KHO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED, VITROS TROP I ES RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED ON THE VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. AN OCD FIELD ENGINEER PERFORMED SERVICE ACTIONS TO MULTIPLE SUBSYSTEMS OF THE ANALYZER AND RETURNED IT TO EXPECTED OPERATION. ADDITIONALLY, THE SAMPLE WAS NOT PROCESSED IN ACCORDANCE WITH THE TUBE MANUFACTURER¿S RECOMMENDATIONS. IT IS LIKELY THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED. THE ROOT CAUSE OF THIS EVENT IS ANALYZER RELATED. HOWEVER, A PRE-ANALYTICAL SAMPLE PROCESSING ISSUE CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR. THERE WAS NO EVIDENCE THAT A REAGENT RELATED ISSUE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A NON-REPRODUCIBLE, HIGHER THAN EXPECTED, VITROS TROP I ES RESULT (0.071 VS. EXPECTED RESULT < 0.034 NG/ML) FROM A SINGLE PATIENT SAMPLE PROCESSED ON THE VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. HOWEVER, THE CUSTOMER TESTS THE TROP I ES SAMPLES IN DUPLICATES AND THE AFFECTED RESULT WAS IDENTIFIED PRIOR TO REPORTING. 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
    73077 VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM IMMUNOASSAY SYSTEM KHO ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1