BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTICS PRODUCTS TROPI ES REAGENT

    MDR report key: 4223237 · Received November 4, 2014

    Report

    Report Number
    3007111389-2014-00240
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    October 4, 2014
    Report Date
    November 4, 2014
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT TWO NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROPI ES RESULTS WERE OBTAINED FROM TWO INDEPENDENT PATIENT SAMPLES WHEN PROCESSED ON A VITROS ECI IMMUNODIAGNOSTIC SYSTEM. REVIEW OF VITROS TROP I ES QUALITY CONTROL RESULTS FROM THE TIME FRAME OF THE EVENT NEITHER IDENTIFIED NOR RULED OUT THE OCCURRENCE OF A REAGENT MALFUNCTION AS THE CONTROL FLUIDS DID NOT HAVE AN EXPECTED TROP I CONCENTRATION SIMILAR TO THAT OF THE PATIENT SAMPLE IN QUESTION. SERVICE ACTIONS WERE COMPLETED, HOWEVER, INSUFFICIENT PERFORMANCE TESTING WAS COMPLETED PRE-SERVICE TO REACH A DEFINITIVE CONCLUSION REGARDING INSTRUMENT PERFORMANCE AT THE TIME OF THE EVENT. THE INVESTIGATION CANNOT RULE OUT PRE-ANALYTICAL SAMPLE PROCESSING AS A CONTRIBUTING FACTOR, AS THE CUSTOMER¿S CENTRIFUGATION PROTOCOL IS NOT ADHERING TO THE SAMPLE COLLECTION DEVICE MANUFACTURER¿S RECOMMENDATIONS FOR SAMPLE CENTRIFUGATION. THE ROOT CAUSE OF THIS EVENT IS UNKNOWN. HOWEVER, AN INSTRUMENT ISSUE, A REAGENT ISSUE, OR PRE-ANALYTICAL SAMPLE PROCESSING CANNOT BE RULED OUT AS POTENTIAL CONTRIBUTING FACTORS.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED TWO NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROPI ES RESULTS FROM TWO INDEPENDENT PATIENT SAMPLES WHEN PROCESSED ON A VITROS ECI IMMUNODIAGNOSTIC SYSTEM. PATIENT 1 TROPI ES= 0.216 NG/ML VS EXPECTED <0.012 NG/ML. PATIENT 2 TROPI ES= 0.067 NG/ML VS EXPECTED <0.012 NG/ML. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE RESULT FOR PATIENT # 1 WAS REPORTED FROM THE LABORATORY; HOWEVER, A CORRECTED REPORT WAS ISSUED TO THE PHYSICIAN. THE RESULT FOR PATIENT # 2 WAS NOT REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THESE TWO EVENTS. THIS REPORT IS NUMBER ONE OF TWO MDRS FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705682 VITROS IMMUNODIAGNOSTICS PRODUCTS TROPI ES REAGENT IN-VITRO DIAGNOSTIC MMI ORTHO-CLINICAL DIAGNOSTICS 1510

    Patients

    Seq Age Sex Outcome Treatment
    1