BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK

    MDR report key: 3864189 · Received June 10, 2014

    Report

    Report Number
    3007111389-2014-00123
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 11, 2014
    Report Date
    June 10, 2014
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. THE INVESTIGATION COULD NOT DETERMINE A DEFINITIVE CAUSE. THE INVESTIGATION COULD NOT DETERMINE WHETHER THE SAMPLE WAS 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 ROOT CAUSE OF THIS EVENT IS UNKNOWN. HOWEVER, A REAGENT RELATED ISSUE, PRE-ANALYTICAL SAMPLE PROCESSING ISSUE OR AN INSTRUMENT RELATED 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=0.18 VS. EXPECTED <0.12 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. IT IS ASSUMED THAT THE CUSTOMER¿S POLICY IS TO CONFIRM TROPI ES RESULTS ABOVE A LABORATORY DEFINED LIMIT. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337835 VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK IN VITRO DIAGNOSTICS MMI ORTHO-CLINICAL DIAGNOSTICS 1450

    Patients

    Seq Age Sex Outcome Treatment
    1