BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK

    MDR report key: 2212727 · Received August 16, 2011

    Report

    Report Number
    3007111389-2011-00112
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 20, 2011
    Report Date
    August 16, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT NON-REPEATABLE FALSELY ELEVATED VITROS TROP I ES RESULTS OCCURRED FROM TWO DIFFERENT PATIENT SAMPLES PROCESSED ON THE VITROS ECIQ SYSTEM. VITROS TROPI ES PRECISION TESTING DEMONSTRATED THE VITROS ECIQ SYSTEM WAS OPERATING AS EXPECTED. THERE WAS NO EVIDENCE FOUND TO SUGGEST AN ANALYZER OR REAGENT MALFUNCTION CONTRIBUTED TO THE HIGHER THAN EXPECTED RESULTS. THE INVESTIGATION CONFIRMED THAT THE TWO SAMPLES INVOLVED WERE NOT PROCESSED IN ACCORDANCE WITH THE TUBE MANUFACTURER'S RECOMMENDATION. IT IS LIKELY THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED. A DEFINITIVE ROOT CAUSE FOR THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED NON-REPEATABLE HIGHER THAN EXPECTED VITROS TROPI ES RESULTS FROM TWO DIFFERENT PATIENT SAMPLES PROCESSED ON A VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. FOR THE SAMPLE FROM PATIENT 1, A VITROS TROPI ES RESULT OF (B)(6) VS. A CORRECT RESULT OF (B)(6) WAS OBTAINED ON (B)(6) 2011. FOR THE SAMPLE FROM PATIENT 2, A VITROS TROPI ES RESULT OF (B)(6) VS. A CORRECT RESULT OF (B)(6) WAS OBTAINED ON (B)(6) 2011. BOTH RESULTS WERE DETECTED AND NOT REPORTED FROM THE LABORATORY. HOWEVER, A BIASED RESULT OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF UNDETECTED. THERE WAS NO ALLEGATION PATIENT HARM. 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. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1