BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECI IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 2073029 · Received April 29, 2011

    Report

    Report Number
    1319681-2011-00102
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    March 30, 2011
    Report Date
    April 29, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JLW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT LOWER THAN EXPECTED VITROS TSH PATIENT RESULTS WERE OBTAINED FOR MULTIPLE SAMPLES FROM A SINGLE PATIENT WHILE USING THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM. THE INVESTIGATION DID NOT DETERMINE A ROOT CAUSE OF THIS EVENT. HOWEVER, A POSSIBLE SAMPLE INTERFERENT AND/OR METHOD TO METHOD DIFFERENCES BETWEEN THE VITROS ECI AND OEM ANALYZERS CANNOT BE RULED OUT AS CONTRIBUTING FACTORS.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED LOWER THAN EXPECTED VITROS TSH PATIENT RESULTS FOR MULTIPLE SAMPLES FROM A SINGLE PATIENT WHILE USING THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE AFFECTED TSH PATIENT RESULTS WERE REPORTED FROM THE LABORATORY AND QUESTIONED BY THE CLINICIAN. NO CORRECTED REPORTS WERE ISSUED. THERE WERE NO ALLEGATIONS OF HARM TO THE PATIENT AS A RESULT OF THIS EVENT. 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 IMMUNODIAGNOSTIC ANALYZER JLW ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1