BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODRAGNOSTIC PRODUCTS TROPONIN I REAGENT

    MDR report key: 585772 · Received May 27, 2004

    Report

    Report Number
    9680658-2004-00106
    Event Type
    Malfunction
    Date Received
    May 27, 2004
    Date of Event
    May 9, 2004
    Report Date
    May 12, 2004
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER REPORTED FALSE HIGH TROPONIN I QC AND PATIENT RESULTS. ELEVATED RESULTSS OF THE MAGNITUDE OBTAINED MIGHT INITIATE INAPPROPRIATE PHYSICIAN ACTION. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS IMMUNODRAGNOSTIC PRODUCTS TROPONIN I REAGENT IN VITRO DIAGNOSTIC MMI ORTHO-CLINICAL DIAGNOSTICS NA 1110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA