BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT

    MDR report key: 3092765 · Received May 3, 2013

    Report

    Report Number
    3007111389-2013-00100
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 4, 2013
    Report Date
    May 3, 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 CONFIRMED THAT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROP I ES PATIENT RESULT WAS OBTAINED WHILE USING THE VITROS 5600 INTEGRATED SYSTEM. AN OCD FE PERFORMED SERVICE ACTIONS TO MULTIPLE SUBSYSTEMS OF THE ANALYZER AND EXPECTED SYSTEM PERFORMANCE WAS OBTAINED FOLLOWING SERVICE. 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. AN INSTRUMENT RELATED ISSUE CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR. ADDITIONALLY, A PRE-ANALYTICAL SAMPLE PROCESSING ISSUE CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR. THERE IS NO EVIDENCE THAT A 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 RESULT (3.75 VS. AN EXPECTED RESULT <0.012 NG/ML) FROM A SINGLE PATIENT SAMPLE PROCESSED ON THE VITROS 5600 INTEGRATED SYSTEM. THE AFFECTED RESULT WAS REPORTED OUT OF THE LABORATORY. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. HOWEVER, THE PHYSICIAN QUESTIONED THE AFFECTED RESULT. THE CUSTOMER RETESTED THE SAMPLE AND A CORRECTED REPORT WAS ISSUED. THERE WAS NO ALLEGATION 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
    193840 VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT IN-VITRO DIAGNOSTIC MMI ORTHO-CLINICAL DIAGNOSTICS 1120

    Patients

    Seq Age Sex Outcome Treatment
    1