BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS TRIPONIN I REAGENT PACK

    MDR report key: 495706 · Received November 13, 2003

    Report

    Report Number
    9680658-2003-00248
    Event Type
    Malfunction
    Date Received
    November 13, 2003
    Report Date
    October 16, 2003
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED GENERATING A FALSELY HIGH TROPININ I RESULT ON ONE PT SAMPLE. THE SAMPLE WAS TREATED WITH A HETEROPHILIC ANTIBODY BLOCKING TUBE AND CORRECT RESULTS WERE GENERATED. A MALFUNCTION OF THIS TYPE COULD CAUSE BIASED RESULTS IN ASSAYS THAT MAY BE USED IN CRITICAL DIAGNOSTIC THE CUSTOMER REPORTED GENERATING A FALSELY HIGH TROPININ I RESULT ON ONE PT SAMPLE. THE SAMPLE WAS TREATED WITH A HETEROPHILIC ANTIBODY BLOCKING TUBE AND CORRECT RESULTS WERE GENERATED. A MALFUNCTION OF THIS TYPE COULD CAUSE BIASED RESULTS IN ASSAYS THAT MAY BE USED IN CRITICAL DIAGNOSTIC APPLICATIONS. THERE WAS NO REPORT OF PT HARM AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA