BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTICS PRODUCTS TROPI ES REAGENT PACK

    MDR report key: 4745396 · Received May 4, 2015

    Report

    Report Number
    3007111389-2015-00107
    Event Type
    Malfunction
    Date Received
    May 4, 2015
    Date of Event
    March 29, 2015
    Report Date
    May 4, 2015
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROPONIN I ES RESULTS WERE OBTAINED FOR TWO PATIENT SAMPLES USING VITROS TROPI ES REAGENT ON A VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. ROOT CAUSE FOR THE EVENTS COULD NOT BE DETERMINED; HOWEVER, PRE-ANALYTICAL SAMPLE HANDLING OR A POSSIBLE VITROS TROPI ES REAGENT ISSUE COULD NOT BE RULED OUT AS CONTRIBUTING FACTORS TO THE EVENTS. THE INVESTIGATION WAS ABLE TO RULE OUT A 5600 SYSTEM MALFUNCTION AS A CONTRIBUTING FACTOR.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROPONIN I ES RESULTS FOR TWO PATIENT SAMPLES USING VITROS TROPI ES REAGENT ON A VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. PATIENT 1 VITROS TROPI ES RESULT: 0.157 NG/ML V S 0.018 NG/ML. PATIENT 2 VITROS TROPI ES RESULT: 0.121 NG/ML V S <0.012 NG/ML. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE RESULT FROM PATIENT 1 WAS REPORTED OUTSIDE OF THE LABORATORY AND A CORRECTED REPORT WAS ISSUED. THE RESULT FROM PATIENT 2 WAS NOT REPORTED FROM THE LABORATORY. THERE WERE NO ALLEGATIONS OF PATIENT HARM MADE AS A RESULT OF THE EVENTS. 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. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291029 VITROS IMMUNODIAGNOSTICS PRODUCTS TROPI ES REAGENT PACK IN-VITRO DIAGNOSTIC MMI ORTHO-CLINICAL DIAGNOSTICS 1755

    Patients

    Seq Age Sex Outcome Treatment
    1