BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT

    MDR report key: 3182533 · Received June 21, 2013

    Report

    Report Number
    3007111389-2013-00122
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 22, 2013
    Report Date
    June 21, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROP I ES PATIENT SERIAL SAMPLE RESULT WAS OBTAINED WHILE USING THE VITROS 5600 SYSTEM. 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 INVESTIGATION COULD NOT DETERMINE A DEFINITIVE ROOT CAUSE. ADDITIONALLY, A PRE-ANALYTICAL SAMPLE PROCESSING ISSUE CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR. THERE IS NO EVIDENCE TO SUGGEST THAT AN INSTRUMENT OR 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 PATIENT SERIAL SAMPLE RESULT (1.13 VS. AN EXPECTED RESULT < 0.012 NG/ML) FROM A SINGLE PATIENT SAMPLE PROCESSED ON THE VITROS 5600 SYSTEM. THE AFFECTED SAMPLE RESULT WAS REPORTED OUT OF THE LABORATORY. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. MEDICAL ACTION WAS TAKEN AND THE PATIENT UNDERWENT A CARDIAC CATHETERIZATION PROCEDURE DUE TO THE AFFECTED RESULT. THE CUSTOMER REPEATED THE SAMPLE DUE TO DISCORDANT SERIAL SAMPLE RESULTS. A CORRECTED REPORT WAS ISSUED. THERE WAS NO REPORT OF PATIENT HARM 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
    283695 VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT IN-VITRO DIAGNOSTIC MMI ORTHO-CLINICAL DIAGNOSTICS 1180

    Patients

    Seq Age Sex Outcome Treatment
    1