BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK

    MDR report key: 2003991 · Received March 1, 2011

    Report

    Report Number
    3007111389-2011-00018
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    January 30, 2011
    Report Date
    March 1, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A NON-REPRODUCIBLE FALSELY ELEVATED VITROS TROP I ES RESULT OCCURRED FROM A PATIENT SAMPLE PROCESSED ON THE VITROS 5600 INTEGRATED SYSTEM. VITROS TROPI ES PRECISION TESTING DEMONSTRATED THE VITROS 5600 SYSTEM WAS OPERATING AS EXPECTED. THERE WAS NO EVIDENCE FOUND TO SUGGEST AN ANALYZER OR REAGENT MALFUNCTION HAD CAUSED THE HIGHER THAN EXPECTED RESULT. THE INVESTIGATION SUSPECTED THAT THE SAMPLE INVOLVED IN THE EVENT MAY NOT HAVE BEEN PROCESSED IN ACCORDANCE WITH THE SAMPLE COLLECTION TUBE MANUFACTURER'S RECOMMENDATION. A DEFINITIVE ROOT CAUSE FOR THE EVENT COULD NOT BE DETERMINED. HOWEVER, PRE-ANALYTICAL SAMPLE PROCESSING CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A NON-REPEATABLE HIGHER THAN EXPECTED VITROS TROPI ES RESULT FROM A PATIENT SAMPLE PROCESSED ON A VITROS 5600 INTEGRATED SYSTEM. A BIASED RESULT OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE HIGHER THAN EXPECTED VITROS TROPI ES RESULT WAS IDENTIFIED AND WAS NOT REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION PATIENT HARM. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (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 0578

    Patients

    Seq Age Sex Outcome Treatment
    1