BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT

    MDR report key: 2991653 · Received March 6, 2013

    Report

    Report Number
    3007111389-2013-00059
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 3, 2013
    Report Date
    March 6, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT MULTIPLE, NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROP I ES RESULTS WERE OBTAINED FROM TWO DIFFERENT PATIENT SAMPLES WHILE USING THE VITROS ECIQ 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 WAS NO EVIDENCE THAT AN INSTRUMENT OR REAGENT RELATED ISSUE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED MULTIPLE, NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROP I ES RESULTS (PATIENT 1= 0.062, PATIENT 2 = 0.057 VS. AN EXPECTED RESULT < 0.012 NG/ML) FROM TWO DIFFERENT PATIENT SAMPLES PROCESSED ON THE VITROS ECIQ SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. HOWEVER, THE CUSTOMER TESTS ALL PATIENT SAMPLES IN DUPLICATES AND THE AFFECTED RESULTS WERE IDENTIFIED PRIOR TO REPORTING. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF TWO MDR'S FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95009 VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT IN-VITRO DIAGNOSTIC MMI ORTHO-CLINICAL DIAGNOSTICS 1080

    Patients

    Seq Age Sex Outcome Treatment
    1