BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK

    MDR report key: 2122219 · Received June 13, 2011

    Report

    Report Number
    3007111389-2011-00079
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 15, 2011
    Report Date
    June 13, 2011
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROP I ES RESULTS WERE OBTAINED FROM MULTIPLE PATIENT SAMPLES PROCESSED ON THE VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. NO REPAIRS HAVE BEEN MADE TO THE INSTRUMENT AT THIS TIME. THE INVESTIGATION DID NOT DETERMINED WHETHER THE SAMPLES IN QUESTION WERE PROCESSED IN ACCORDANCE WITH THE TUBE MANUFACTURER'S RECOMMENDATIONS. CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, MAY HAVE BEEN PRESENT IN THE AFFECTED SAMPLES, ALTHOUGH THIS COULD NOT BE CONFIRMED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, PRE-ANALYTICAL SAMPLE PROCESSING OR AN INSTRUMENT RELATED EVENT CANNOT BE RULED OUT AS CONTRIBUTING FACTORS. THE ROOT CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED MULTIPLE NON-REPRODUCIBLE HIGHER THAN EXPECTED VITROS TROP I ES RESULTS FROM PATIENT SAMPLES (PATIENT 1"0.080 NG/ML" COMPARED TO "0" AND PATIENT 2 "0.070 NG/ML COMPARED TO 0.014 NG/ML) WHEN PROCESSING ON THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE AFFECTED RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4). NOTE: THIS IS ONE OF TWO 3500A FORMS BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED.

    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 0640

    Patients

    Seq Age Sex Outcome Treatment
    1