BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE TURBO TROPONIN KIT

    MDR report key: 309281 · Received December 15, 2000

    Report

    Report Number
    2017183-2000-00002
    Event Type
    Malfunction
    Date Received
    December 15, 2000
    Date of Event
    November 17, 2000
    Manufacturer
    DIAGNOSTIC PRODUCTS CORPORATION
    Product Code
    LYR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING FALSELY ELEVATED TEST RESULTS WITH THIS KIT. SUBSEQUENTLY, THE PT WAS TREATED, ALTHOUGH LATER INVESTIGATION DETERMINED THAT TREATMENT WAS NOT NECESSARY. TREATMENT WAS NOT A SERIOUS INJURY; HOWEVER IT COULD HAVE POSSIBLY BEEN UNDER DIFFERENT CIRCUMSTANCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE TURBO TROPONIN KIT IN-VITRO DIAGNOSTIC TEST KIT LYR DIAGNOSTIC PRODUCTS CORPORATION N/A 114

    Patients

    Seq Age Sex Outcome Treatment
    1 *