BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACS:180 BR IMMUNOASSAY

    MDR report key: 175581 · Received July 1, 1998

    Report

    Report Number
    62015-1998-00005
    Event Type
    Other
    Date Received
    July 1, 1998
    Date of Event
    January 1, 1998
    Report Date
    June 2, 1998
    Manufacturer
    CHIRON DIAGNOSTICS CORP.
    Product Code
    JJE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ACS BR TEST WAS USED TO MONITOR A PT. THE TEST IS INTENDED FOR USE AS AN AID IN THE MANAGEMENT OF BREAST CANCER AND THE EARLY DETECTION OF BREAST CANCER RECURRENCE. THE BREAST CANCER PT HAD BEEN MONITORED WITH ANOTHER MFR'S TEST WITH NO RECURRENCE OF DISEASE FOR APPROX. 5 YEARS. THE PT BEGAN BEING MONITORED WITH THE ACS BR TEST IN APRIL. INITIAL RESULTS WERE REPORTED AS SLIGHTLY BELOW THE UPPER LIMIT IF NORMAL FOR THE TEST (38.6). ON MAY 26, 1998 THE PT WAS RETESTED AND A RESULT OF 54 WAS REPORTED. BASED ON THIS RESULT ADDITIONAL WORKUP OF THE PT WAS PERFORMED. THIS INCLUDED A COMPETERIZED AXIAL TOMOGRAPHY SCAN , MAGNETIC RESONANCE IMAGING, BONE SCAN AND LIVER BIOPSY. ALL THESE RESULTS REVEALED NO EVIDENCE OF DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS:180 BR IMMUNOASSAY IN VITRO DIAGNOSTIC IMMUNOASSAY JJE CHIRON DIAGNOSTICS CORP. * 86

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other