BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPI ES REAGENT PACK

    MDR report key: 4861825 · Received June 23, 2015

    Report

    Report Number
    3007111389-2015-00161
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    March 28, 2015
    Report Date
    June 23, 2015
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS DETERMINED THAT A RETROSPECTIVE REVIEW OF ECONNECTIVITY DATA FOR AN INTERNAL ORTHO CLINICAL DIAGNOSTIC INVESTIGATION FOUND TWO NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROPI ES RESULTS OBTAINED FROM TWO DIFFERENT PATIENT SAMPLES USING VITROS TROPI ES REAGENT ON A VITROS 5600 INTEGRATED SYSTEM. ROOT CAUSE FOR THE UNEXPECTED RESULTS COULD NOT BE DETERMINED WITH THE INFORMATION AVAILABLE, HOWEVER THE POSSIBILITY THAT AN UNEXPECTED VITROS TROPONIN I ES REAGENT PERFORMANCE OR AN UNEXPECTED VITROS 5600 SYSTEM PERFORMANCE HAD CONTRIBUTED TO THE RESULTS COULD NOT BE RULED OUT ENTIRELY. THE INVESTIGATION IS ONGOING INTO THE PERFORMANCES OF VITROS TROPONIN I ES KIT LOTS >=1710.

    Description of Event or Problem · 1

    A RETROSPECTIVE REVIEW OF ECONNECTIVITY DATA FOR AN INTERNAL ORTHO CLINICAL DIAGNOSTIC INVESTIGATION FOUND TWO NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROPI ES RESULTS OBTAINED FROM TWO DIFFERENT PATIENT SAMPLES USING VITROS TROPI ES REAGENT ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT SAMPLE 1 RESULT: 0.097 NG/ML VS EXPECTED 0.027 NG/ML; PATIENT SAMPLE 2 RESULT: 0.067 NG/ML VS EXPECTED 0.033 NG/ML. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION. IT IS UNKNOWN IF THE RESULTS WERE REPORTED TO A CLINICIAN. IT IS ASSUMED THAT THE UNEXPECTED RESULTS WOULD HAVE BEEN CAPTURED BY THE FACILITY'S DELTA CHECK. SINCE THE CUSTOMER DID NOT REPORT THESE RESULTS DIRECTLY TO ORTHO CLINICAL DIAGNOSTICS, IT IS ASSUMED THERE WERE NO ALLEGATIONS OF PATIENT HARM. THIS REPORT IS NUMBER ONE 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. COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406496 VITROS IMMUNODIAGNOSTIC PRODUCTS TROPI ES REAGENT PACK IN-VITRO DIAGNOSTIC MMI ORTHO-CLINICAL DIAGNOSTICS 1760

    Patients

    Seq Age Sex Outcome Treatment
    1