BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT

    MDR report key: 3061925 · Received April 16, 2013

    Report

    Report Number
    3007111389-2013-00093
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 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 WAS NO EVIDENCE THAT AN INSTRUMENT RELATED AND/OR A REAGENT RELATED ISSUE CONTRIBUTING TO THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED MULTIPLE NON- REPRODUCIBLE, HIGHER THAN EXPECTED, VITROS TROP I ES RESULTS (0.122 VS. EXPECTED RESULT <0.012; 0.166 VS. EXPECTED RESULT =0.031 NG/ML) FROM TWO DIFFERENT PATIENT SAMPLES PROCESSED ON THE VITROS 5600 SYSTEM. THE AFFECTED RESULTS WERE REPORTED OUT OF THE LABORATORY. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. HOWEVER, THE AFFECTED RESULTS WERE QUESTIONED BY EACH PATIENT'S PHYSICIAN. THE CUSTOMER REPEAT TESTED THE SAMPLES AND CORRECTED REPORTS WERE ISSUED. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162893 VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT IN-VITRO DIAGNOSTIC MMI ORTHO-CLINICAL DIAGNOSTICS 1120

    Patients

    Seq Age Sex Outcome Treatment
    1