BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK

    MDR report key: 3950300 · Received July 22, 2014

    Report

    Report Number
    3007111389-2014-00161
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 21, 2014
    Report Date
    July 22, 2014
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED TROPONIN I ES RESULT WAS OBTAINED FROM A PATIENT SAMPLE WHILE USING THE VITROS 5600 INTEGRATED SYSTEM. THERE WAS NO INDICATION THAT AN INSTRUMENT ISSUE CONTRIBUTED TO THE EVENT. THE INVESTIGATION DETERMINED THE SAMPLE WAS NOT PROCESSED IN ACCORDANCE WITH THE TUBE MANUFACTURER¿S RECOMMENDATIONS. IT IS POSSIBLE THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED. THE ASSIGNABLE CAUSE OF THIS EVENT IS UNKNOWN. HOWEVER, A PRE-ANALYTICAL SAMPLE HANDLING AND A REAGENT ISSUE CANNOT BE RULED OUT AS POTENTIAL CONTRIBUTING FACTORS.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A NON-REPRODUCIBLE, HIGHER THAN EXPECTED TROPONIN I ES RESULT (TROPONIN=0.066 VS. EXPECTED 0.030 NG/ML) FROM A PATIENT SAMPLE PROCESSED ON A VITROS 5600 INTEGRATED SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THE RESULTS WERE TO RECUR UNDETECTED. THE CUSTOMER REPEATED THE AFFECTED SAMPLES PRIOR TO REPORTING AS IT IS ASSUMED IT IS THE CUSTOMER¿S POLICY TO CONFIRM TROPI ES RESULTS ABOVE A LABORATORY DEFINED LIMIT. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429126 VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK IN VITRO DIAGNOSTICS MMI ORTHO-CLINICAL DIAGNOSTICS 1481

    Patients

    Seq Age Sex Outcome Treatment
    1