BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS:180 BR IMMUNOASSAY

    MDR report key: 171862 · Received June 9, 1998

    Report

    Report Number
    1219913-1998-00003
    Event Type
    Malfunction
    Date Received
    June 9, 1998
    Report Date
    May 11, 1998
    Manufacturer
    CHIRON DIAGNOSTICS CORP
    Product Code
    MOI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CHIRON DIAGNOSTIC ACS:180 BR TEST HAS MALFUNCTIONED AND IT APPEARS THAT THE POTENTIAL MAY EXIST FOR CERTAIN DISCREPANT RESULTS ON CERTAIN TYPES OF PTS. IT APPEARS THAT RARE SAMPLES MAY CONTAIN HETEROPHILIC ANTIBODIES WHICH REACT WITH ASSAY REAGENT AND CAUSE INTERFERENCE. THIS IS DULY NOTED IN PRODUCT LABELING. ADDITIONALLY, STUDIES SUGGEST THAT INTERFERING SUBSTANCE IS UNIQUE ENTITY WITH CHARACTERISTICS OF ANTI-INDIOTYPIC ANTIBODY. IN THIS SPECIFIC EVENT, LABORATORY REPORTED ACS "BR" (CA27.29) SERUM TEST RESULT OF 400 NG/ML. TEST WAS REPEATED AND RESULTED IN EQUIVALENT ELEVATED VALUES.THE UPPER LIMIT OF NORMAL AS STATED IN PACKAGE INSERT IS 38.6 NG/ML. SUBSEQUENT TESTING BY ANOTHER MANUFACTURER'S TEST INDICATED RESULT OF 19 NG/ML WHICH IS NEGATIVE. AS RESULT OF ACS "BR" TESTS AND THE FACT THAT PREVIOUS "BR" TESTS HAS BEEN NEGATIVE WITH ANOTHER TEST, CLINICIAN EMBARKED WORKUP OF PT FOR OCCULT/SUBCLINICAL RECURRENT DISEASE. IT WAS REPORTED THAT PT HAD A LOT OF NONSPECIFIC SYMPTOMS WHICH RESULTED IN SERIES OF TEST TO DETERMINE FOR CANCER RECURRENCE. IMAGING TESTS INCLUDED COMPUTERIZED TOMOGRAPHY SCAN, BONE SCAN, BRACHIAL PLEXUS COMPUTERIZED TOMOGRAPHY MAGNETIC RESONANCE IMAGING TO RULE OUT BRACHIAL PLEXUS INVASION BY TUMOR (PT HAD NONSPECIFIC PAIN AND TINGLING IN ONE ARM), HEAD AND NECK COMPUTERIZED TOMOGRAPHY MAGNETIC RESONANCE IMAGING TO RULE OUT CENTRAL NERVOUS SYSTEM DISEASE. MOST OF SCANS WERE READ AS NORMAL BUT SOME NONSPECIFIC ABNORMALITIES WERE NOTED IN LIVER COMPUTERIZED TOMOGRAPHY SCAN). BECAUSE SOME NONSPECIFIC CHANGES WERE NOTED ON THE LIVER SCAN, DECISION WAS MADE TO SAMPLE AREA WITH COMPUTERIZED TOMOGRAPHY DIRECTED LIVER BIOPSY. UNDER COMPUTERIZED TOMOGRAPHY GUIDANCE, NEEDLE BIOPSY OF "ABNORMALITY" WAS OBTAINED AND PATH REPORT CAME BACK AS NORMAL LIVER TISSUE WITH NO EVIDENCE OF MALIGNANT CELLS. PT ALSO UNDERWENT LUMBER PUNCTURE(SPINAL TAP) IN ORDER TO RULE OUT CARCINOMATOUS MENINGITIS(INVASION OF THE BRAIN/SPINAL CORD BY TUMOR). SPINAL FLUID SHOWED NO EVIDENCE OF TUMOR CELLS. FOLLOWING IMAGING WORKUP AND EXTENSIVE BIOCHEMICAL EVAL(COMPLETE BLOOD CELL COUNT, "SMAC" PANEL, LIVER FUNCTION TESTS ETC), NO EVIDENE OF RECURRENT/METASTATIC DISEASE WAS DOCUMENTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS:180 BR IMMUNOASSAY IN VITRO DIAGNOSTIC IMMUNOASSAY MOI CHIRON DIAGNOSTICS CORP * 84

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other