BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPI ES REAGENT PACK

    MDR report key: 4899943 · Received July 8, 2015

    Report

    Report Number
    3007111389-2015-00202
    Event Type
    Injury
    Date Received
    July 8, 2015
    Date of Event
    June 11, 2015
    Report Date
    July 8, 2015
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT MULTIPLE NON-REPRODUCIBLE, HIGHER THAN EXPECTED TROPONIN I RESULTS WERE OBTAINED FROM TWO DIFFERENT PATIENT SAMPLES AND A KNOWN TROPONIN I FREE SAMPLE PROCESSED ON A VITROS 5600 INTEGRATED SYSTEM USING TWO TROPI ES REAGENT LOTS. THE ASSIGNABLE CAUSE FOR THE SAMPLE 1 EVENT COULD NOT BE DETERMINED; HOWEVER, PRE-ANALYTICAL SAMPLE PROCESSING COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR. AN INSTRUMENT RELATED EVENT OR VITROS TROPI ES REAGENT ISSUE HAVE BEEN RULED OUT AS POSSIBLE CONTRIBUTING FACTORS. THE ASSIGNABLE CAUSE FOR THE SAMPLES 2 AND 3 EVENTS COULD NOT BE DETERMINED; HOWEVER, PRE-ANALYTICAL SAMPLE PROCESSING OR A TRANSIENT VITROS TROPI ES REAGENT ISSUE COULD NOT BE RULED OUT AS POSSIBLE CONTRIBUTING FACTORS. THE INVESTIGATION WAS ABLE TO RULE OUT AN INSTRUMENT RELATED PROBLEM. THE ASSIGNABLE CAUSE FOR THE HIGHER THAN EXPECTED RESULT OBTAINED FROM THE TROPONIN I FREE SAMPLE WAS AN INSTRUMENT RELATED ISSUE, AS WITHIN RUN PRECISION TESTING WAS UNACCEPTABLE PRIOR TO SERVICING. ACCEPTABLE PERFORMANCE WAS OBTAINED AFTER OCD FIELD SERVICE WAS PERFORMED.

    Description of Event or Problem · 1

    A CUSTOMER COMPLAINED THAT MULTIPLE NON-REPRODUCIBLE, HIGHER THAN EXPECTED TROPONIN I RESULTS WERE OBTAINED FROM TWO DIFFERENT PATIENT SAMPLES AND A KNOWN TROPONIN I FREE SAMPLE PROCESSED ON A VITROS 5600 INTEGRATED SYSTEM USING TWO TROPI ES REAGENT LOTS. TROPI ES LOT 1760. SAMPLE 1 RESULT: 0.238 NG/ML VS EXPECTED <0.012 NG/ML. TROPI ES LOT 1850. TROPONIN I FREE SAMPLE RESULT: 0.062 NG/ML VS EXPECTED <0.012 NG/ML. SAMPLE 2 RESULT: 0.482 NG/ML VS EXPECTED <0.012 NG/ML. SAMPLE 3 RESULT: 0.388 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 SAMPLE 1 WAS REPORTED OUTSIDE OF THE LABORATORY AND A CORRECTED REPORT WAS LATER ISSUED. BASED ON THE INITIAL REPORTED RESULT, THE PATIENT CHOSE TO HAVE A CARDIAC CATHETERIZATION PERFORMED; THE RESULT WAS NEGATIVE, AND IT WAS CONFIRMED THAT THERE WAS NO ADVERSE EFFECT ON THE PATIENT. THE RESULTS FOR SAMPLE 2 AND SAMPLE 3 WERE NOT REPORTED OUT OF THE LABORATORY, AND THERE WERE NO ALLEGATIONS OF PATIENT HARM AS A RESULT OF THESE EVENTS. THIS REPORT IS NUMBER THREE OF THREE MDR¿S FOR THIS EVENT. THREE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS THREE DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBERS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443361 VITROS IMMUNODIAGNOSTIC PRODUCTS TROPI ES REAGENT PACK IN-VITRO DIAGNOSTIC MMI ORTHO-CLINICAL DIAGNOSTICS 1760

    Patients

    Seq Age Sex Outcome Treatment
    1