BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK

    MDR report key: 2111936 · Received June 2, 2011

    Report

    Report Number
    3007111389-2011-00065
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 2, 2011
    Report Date
    June 2, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT REPRODUCIBLE HIGHER THAN EXPECTED VITROS TROP I ES RESULTS WERE OBTAINED FOR TWO SAMPLES FROM A SINGLE PATIENT PROCESSED ON TWO VITROS ECI IMMUNODIAGNOSTIC SYSTEMS. THERE WAS NO EVIDENCE TO SUGGEST AN INSTRUMENT OR REAGENT MALFUNCTION HAD OCCURRED. TREATING THE SAMPLE USING A HETEROPHILIC BLOCKING TUBE YIELDED LOWER RESULTS THAN THE UNTREATED SAMPLE. THE MOST LIKELY CAUSE OF THE EVENT IS THE PRESENCE OF HETEROPHILIC ANTIBODIES IN THE PATIENT SAMPLE THAT ARE INTERFERING WITH THE ASSAY. THE VITROS TROP I ES INSTRUCTIONS FOR USE STATE, "FOR TROUBLESHOOTING PURPOSES, IF THE CTNI RESULT IS INCONSISTENT WITH THE CLINICAL PICTURE AND IS PERSISTENTLY ELEVATED, THE SAMPLE SHOULD BE TESTED FOR THE PRESENCE OF HETEROPHILIC ANTIBODIES. THESE ANTIBODIES MAY BE PRESENT IN THE BLOOD SAMPLES FROM INDIVIDUALS REGULARLY EXPOSED TO ANIMALS OR WHO HAVE BEEN TREATED WITH ANIMAL SERUM PRODUCTS."

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED REPRODUCIBLE HIGHER THAN EXPECTED VITROS TROP I ES RESULTS (2.63, 2.65, 2.68, 2.60, 0.177 NG/ML) FOR TWO SAMPLES FROM A SINGLE PATIENT PROCESSED ON TWO VITROS ECI IMMUNODIAGNOSTIC SYSTEMS. THE VITROS TROP I ES RESULTS WERE CONSIDERED TO BE HIGHER THAN EXPECTED BASED ON VALUES OBTAINED USING AN ALTERNATE METHOD (0.01 NG/ML). BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. A HIGHER THAN EXPECTED RESULT WAS REPORTED OUT OF THE LABORATORY, AND A CARDIAC CATHETERIZATION WAS PERFORMED. HOWEVER, THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK IN-VITRO DIAGNOSTIC MMI ORTHO-CLINICAL DIAGNOSTICS 631

    Patients

    Seq Age Sex Outcome Treatment
    1