BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPI ES REAGENT

    MDR report key: 2241857 · Received September 9, 2011

    Report

    Report Number
    3007111389-2011-00131
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 11, 2011
    Report Date
    September 9, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A NON-REPRODUCIBLE FALSELY ELEVATED TROP I ES RESULT OCCURRED ON A SINGLE PATIENT SAMPLE PROCESSED ON A VITROS ECI IMMUNODIAGNOSTIC SYSTEM. A DEFINITIVE ASSIGNABLE CAUSE COULD NOT BE DETERMINED, HOWEVER, THE EFFECT OF SAMPLE PROCESSING (CENTRIFUGATION) COULD NOT BE RULED OUT AS A POTENTIAL CAUSE. THE INVESTIGATION DETERMINED THAT THE CUSTOMER HAD PROCESSED THE PATIENT SAMPLES OUTSIDE THE SAMPLE COLLECTION TUBE MANUFACTURER'S RECOMMENDATIONS FOR CENTRIFUGATION TIME AND SPEED. IT IS POSSIBLE THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED. ALL PRE-SERVICE TROPI ES PERFORMANCE TESTS WERE ACCEPTABLE, INDICATING THE ECI SYSTEM WAS PERFORMING AS INTENDED AND THE TROPI ES REAGENT DID NOT MALFUNCTION.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A NON-REPRODUCIBLE, FALSELY ELEVATED VITROS TROPI ES RESULT FROM A SINGLE PATIENT SAMPLE (3.72 NG/ML) PROCESSED ON A VITROS ECI IMMUNODIAGNOSTICS SYSTEM. THE SAME SAMPLE WAS RETESTED IN DUPLICATE AND THE REPEAT RESULTS OBTAINED (0.022, 0.021 NG/ML)WERE BELIEVED TO BE THE ACCURATE RESULTS. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE NON-REPRODUCIBLE, FALSELY ELEVATED TROPI ES RESULT WAS REPORTED OUTSIDE THE LABORATORY, HOWEVER, NO ACTION WAS TAKEN BY THE PHYSICIAN AND THERE WAS NO ALLEGATION OF PATIENT HARM. NO CORRECTED REPORT WAS ISSUED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS IMMUNODIAGNOSTIC PRODUCTS TROPI ES REAGENT IN-VITRO DIAGNOSTIC MMI ORTHO-CLINICAL DIAGNOSTICS 0700

    Patients

    Seq Age Sex Outcome Treatment
    1