BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS:180 BR IMMUNOASSAY

    MDR report key: 175321 · Received June 29, 1998

    Report

    Report Number
    62015-1998-00004
    Event Type
    Malfunction
    Date Received
    June 29, 1998
    Date of Event
    January 1, 1998
    Report Date
    May 28, 1998
    Manufacturer
    CHIRON DIAGNOSTICS CORP.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ACS BR TEST WAS PERFORMED ON 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. AN INITIAL RESULT OF 180 WAS REPORTED ON APRIL 28, 1998. THE PT HAD NO INDICATIONS OF CANCER. ON MAY 28, 1998 IT WAS REPORTED THAT THE TREATING PHYSICIAN HAD PERFORMED AND MAGNETIC RESONANCE IMAGING AND A MAMMOGRAM ON THE PT. THE PT REPORTEDLY HAD THROMBOSIS OF THE ARM AS ORIGINAL SYMPTOMS. THE ORIGINAL LAB RESULTS WAS 180, IT WAS LATER REPEATED AND REPORTED AS 150, AS SERUM SAMPLE WAS SENT TO CHIRON DIAGNOSTICS AND THE IN HOUSE LAB REPORTED A VALVE OF 127. THE SERUM WAS SUBSEQUENTLY ANALYZED ON A MODIFIED VERSION OF THE ASSAY AND A 25.5 WAS OBTAINED. THIS CONFIRMED THAT THE ORIGINAL RESULT WAS DISCREPANT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other