BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK

    MDR report key: 4020243 · Received August 19, 2014

    Report

    Report Number
    3007111389-2014-00185
    Event Type
    Malfunction
    Date Received
    August 19, 2014
    Date of Event
    July 21, 2014
    Report Date
    August 19, 2014
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT NON-REPRODUCIBLE, HIGHER THAN EXPECTED TROPONIN I ES RESULTS WERE OBTAINED FROM TWO SAMPLES FROM THE SAME PATIENT WHILE USING THE VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. THE INVESTIGATION COULD NOT DETERMINE AN ASSIGNABLE CAUSE. THERE WAS NO INDICATION THAT AN INSTRUMENT ISSUE OR A REAGENT ISSUE CONTRIBUTED TO THE EVENT. THE INVESTIGATION COULD NOT DETERMINE WHETHER THE SAMPLE WAS PROCESSED IN ACCORDANCE WITH THE TUBE MANUFACTURER¿S RECOMMENDATIONS. IT IS POSSIBLE THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED. THE ASSIGNABLE CAUSE OF THIS EVENT IS UNKNOWN. HOWEVER, A PRE-ANALYTICAL SAMPLE HANDLING ISSUE CANNOT BE RULED OUT AS POTENTIAL CONTRIBUTING FACTOR.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROPONIN I ES RESULTS FROM TWO SAMPLES DRAWN FROM THE SAME PATIENT (SAMPLE 1= 0.070 VS. EXPECTED <0.012 NG/ML; SAMPLE 2 = 0.060 VS. EXPECTED <0.012 NG/ML) PROCESSED ON A VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THE RESULTS WERE TO RECUR UNDETECTED. THE HIGHER THAN EXPECTED TROPONIN I ES RESULTS WERE NOT REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO 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
    499837 VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK IN VITRO DIAGNOSTICS MMI ORTHO-CLINICAL DIAGNOSTICS 1540

    Patients

    Seq Age Sex Outcome Treatment
    1