BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK

    MDR report key: 855104 · Received May 24, 2007

    Report

    Report Number
    9680658-2007-00141
    Event Type
    Malfunction
    Date Received
    May 24, 2007
    Date of Event
    March 11, 2007
    Report Date
    April 26, 2007
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Removal / Correction Number
    9680658-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT IS ONGOING. FLUIDS THAT CONTAIN TROPONIN I AT LEVELS BELOW 0.2 NG/ML CAN SHOW A NEGATIVE BIAS. RESULTS ABOVE 0.2 NG/ML ARE NOT AFFECTED BY THIS ISSUE. THE TROPONIN I CUT OFF FOR MYOCARDIAL INFARCTION IS 0.4 NG/ML. THE FAILURE ANALYSIS TO DATE HAS DETERMINED THAT ONLY TWO REAGENT LOTS ARE IMPLICATED IN THE MALFUNCTION. THE ROOT CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED NEGATIVELY BIASED TROPONIN I QUALITY CONTROL RESULTS FOR ONE OF THE THREE CONTROL FLUIDS. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK IN VITRO DIAGNOSTIC MMI ORTHO-CLINICAL DIAGNOSTICS NA 3170

    Patients

    Seq Age Sex Outcome Treatment
    1 YR