BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECI IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 982316 · Received January 22, 2008

    Report

    Report Number
    1319681-2008-00020
    Event Type
    Malfunction
    Date Received
    January 22, 2008
    Date of Event
    December 21, 2007
    Report Date
    December 24, 2007
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT DETERMINED THAT POSITIVELY BIASED TROPONIN I RESULTS WERE OBTAINED USING THE VITROS IMMUNODIAGNOSTICS PRODUCTS TROPI ES REAGENT ON A VITROS ECI ANALYZER IN LATE 2007. AN OCD FIELD ENGINEER WENT ON SITE ON THE NEXT DAY, AND DETERMINED THAT THE VITROS ECI ANALYZER REAGENT PROBE RACK WAS LOOSE WHICH COULD RESULT IN POSITIVELY BIASED TROPI ES RESULT. THE FIELD ENGINEER REPAIRED THE PROBE RACK RETURNING THE INSTRUMENT TO EXPECTED OPERATION. QUALITY CONTROL RESULTS AND ADDITIONAL PATIENT SAMPLES RUN AFTER THE REPAIR HAVE CONFIRMED ACCEPTABLE PERFORMANCE. THE PATIENT RESULT IN QUESTION (REPORTED ON DEC 21 2007) WAS REPORTED AND THE PATIENTS PHYSICIAN TOOK ACTION. AFTER IT WAS DETERMINED THAT THE RESULTS WERE POSITIVELY BIASED, THE PHYSICIAN WAS CONTACTED AND DISCONTINUED THE MEDICAL TREATMENT THAT WAS STARTED BASED ON THE POSITIVELY BIASED TROPI RESULT. THE LABORATORY MEDICAL DIRECTOR DETERMINED THAT NO PATIENT HARM OCCURRED AS A RESULT OF THIS EVENT. THE OTHER SAMPLES THAT SHOWED POSITIVELY BIASED RESULTS WERE NOT REPORTED BECAUSE THE CUSTOMER BEGAN RUNNING DUPLICATE RESULTS TO EVALUATE THE INSTRUMENT PERFORMANCE UNTIL SERVICE HAD BEEN PERFORMED. THERE WAS NO REPORT OF PATIENT HARM FOR THESE SAMPLES. THE ROOT CAUSE OF THIS EVENT WAS INSTRUMENT RELATED.

    Description of Event or Problem · 1

    A CUSTOMER CALLED THE OCD TECHNICAL SUPPORT CENTER IN LATE 2007 TO REPORT THAT THEY HAD REPORTED A POSITIVELY BIASED TROPONIN I RESULT FROM THEIR VITROS ECI ANALYZER USING VITROS IMMUNODIAGNOSTICS PRODUCTS TROPL ES REAGENT. THE PATIENTS PHYSICIAN WAS ADVISED OF THE MISREPORTED RESULT AND DISCONTINUED MEDICAL TREATMENT THAT HAD BEEN ORDERED AS A RESULT OF THE INITIAL SAMPLE RESULT. THERE WAS A REPORT OF A MISREPORTED RESULT, BUT NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS ECI IMMUNODIAGNOSTIC SYSTEM IMMUNODIAGNOSTIC ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1