BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT

    MDR report key: 3140499 · Received May 31, 2013

    Report

    Report Number
    3007111389-2013-00115
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 4, 2013
    Report Date
    May 31, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT MULTIPLE, NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROP I ES RESULTS WERE OBTAINED FROM TWO DIFFERENT PATIENT SAMPLES PROCESSED ON THE VITROS ECIQ SYSTEM. ADDITIONALLY, THE SAMPLES WERE 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. ROOT CAUSE FOR AFFECTED PATIENT 1 RESULTS: THE INVESTIGATION COULD NOT DETERMINE A DEFINITIVE ROOT CAUSE. ADDITIONALLY, A PRE-ANALYTICAL SAMPLE PROCESSING OR A REAGENT RELATED ISSUE CANNOT BE RULED OUT AS CONTRIBUTING FACTORS. THERE WAS NO EVIDENCE THAT AN INSTRUMENT RELATED ISSUE CONTRIBUTED TO THE EVENT. ROOT CAUSE FOR AFFECTED PATIENT 2 RESULTS: AN OCD FE PERFORMED SERVICE ACTIONS TO RETURN THE SYSTEM TO EXPECTED PERFORMANCE. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY CAUSE OF THE EVENT IS INSTRUMENT RELATED. ADDITIONALLY, A PRE-ANALYTICAL SAMPLE PROCESSING ISSUE CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED MULTIPLE, NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROP I ES RESULTS FROM TWO DIFFERENT PATIENT SAMPLES PROCESSED ON THE VITROS ECIQ SYSTEM. THE FOLLOWING RESULTS WERE OBTAINED: PATIENT 1 = 0.144 VS. AN EXPECTED RESULT = 0.03 NG/ML; PATIENT 2 = 0.19 VS. AN EXPECTED RESULT < 0.012 NG/ML; BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE CUSTOMER REPEATED THE AFFECTED SAMPLES PRIOR TO REPORTING AS IT IS ASSUMED THAT THE CUSTOMER¿S POLICY IS TO CONFIRM TROP I RESULTS ABOVE A LABORATORY DEFINED LIMIT. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF TWO MDR¿S FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240884 VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT IN-VITRO DIAGNOSTIC MMI ORTHO-CLINICAL DIAGNOSTICS 1180

    Patients

    Seq Age Sex Outcome Treatment
    1