BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATUS CARDIAC TROPONIN-I FLUOROMETRIC ENZYME IMMUNOASSAY

    MDR report key: 145242 · Received January 19, 1998

    Report

    Report Number
    1025506-1998-00001
    Event Type
    Malfunction
    Date Received
    January 19, 1998
    Date of Event
    November 14, 1997
    Report Date
    January 19, 1998
    Manufacturer
    DADE INTL., INC.
    Product Code
    LGP
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    CUSTOMER CALLED INTO STRATUS TECHNICAL SERVICES REQUESTING THAT CO TEST A PT SAMPLE FOR THEM. THEY INDICATED THAT THEY HAD A PT SAMPLE WITH A TROPONIN-I RESULT OF <0.35 NG/ML (NEGATIVE). THEY SENT THE SAMPLE TO A SISTER HOSPITAL FOR TESTING AND THE RESULT WAS POSITIVE. NO PT INFO WAS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATUS CARDIAC TROPONIN-I FLUOROMETRIC ENZYME IMMUNOASSAY TROPONIN-I LGP DADE INTL., INC. * KXTN-670

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening