BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK

    MDR report key: 2882223 · Received December 20, 2012

    Report

    Report Number
    3007111389-2012-00256
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    December 3, 2012
    Report Date
    December 20, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROP I ES RESULT WAS OBTAINED FROM A SINGLE PATIENT RUN ON THE VITROS 5600 SYSTEM. THERE WAS NO EVIDENCE TO SUGGEST AN INSTRUMENT/ REAGENT MALFUNCTION HAD OCCURRED. 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. A DEFINITIVE ROOT CAUSE FOR THE EVENT COULD NOT BE DETERMINED. HOWEVER, A PRE-ANALYTICAL SAMPLE PROCESSING ISSUE COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROP I ES RESULT (0.148 VS. EXPECTED RESULTS <0.012 NG/ML) FROM A SINGLE PATIENT RUN ON THE VITROS 5600 SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. HOWEVER, THE HIGHER THAN EXPECTED RESULT WAS NOT REPORTED FROM THE LABORATORY. THE CUSTOMER RETESTED THE SAMPLE IN DUPLICATES PER CUSTOMER POLICY PRIOR TO REPORTING. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. (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 1000

    Patients

    Seq Age Sex Outcome Treatment
    1