BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 H. PYLORI IGG

    MDR report key: 328278 · Received April 18, 2001

    Report

    Report Number
    2017183-2001-00001
    Event Type
    Malfunction
    Date Received
    April 18, 2001
    Manufacturer
    DIAGNOSTIC PRODUCTS CORP.
    Product Code
    LYR
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DPC RECEIVED A REPORT OF DISCREPANT RESULTS OBSERVED WITH IMMULITE 2000 H. PYLORI, KIT LOT L2KHEQ 104. A REVIEW OF IN-HOUSE QUALITY CONTROL DATA INDICATED THAT THE KIT WAS PERFORMING WITHIN SPECIFICATIONS. THE DISCREPANT SAMPLES WERE SENT TO DPC-LA FOR TESTING. THE DISCORDANT RESULTS WERE CONFIRMED TO BE FALSE POSITIVES. THE INVESTIGATION IDENTIFIED THE ROOT CAUSE AS THE ANTIGEN USED TO COAT THE BEAT COMPONENT. NEW PROCEDURES HAVE BEEN IMPLEMENTED TO IMPROVE ANTIGEN CONFORMANCE TESTING. THE IMMULITE H. PYLORI AND IMMULITE 2000 H. PYLORI ASSAYS ARE INTENDED TO BE USED AS AN AID IN THE DIAGNOSIS OF H. PYLORI INFECTION IN SYMPTOMATIC INDIVIDUALS. BREATH TESTS AND ENDOSCOPIC RESULTS ARE FREQUENTLY USED IN CONJUNCTION WITH BLOOD SEROLOGICAL TESTS TO CONFIRM INFECTION. DUE TO THE PREVALENCE OF ANTIBODIES TO H. PYLORI IN THE GENERAL POPULATION, A POSITIVE H. PYLORI RESULT MAY NOT INDICATE AN ACTIVE INFECTION OR THAT THE EXISTING SYMPTOMS, IF PRESENT, ARE THE RESULT OF H. PYLORI INFECTION. INFECTION MAY HAVE OCCURRED SOME TIME IN THE PAST AND MAY BE UNRELATED TO THE REPORTED SYMPTOMS. A POSITIVE H. PYLORI TEST MAY LEAD TO ANTIBIOTIC TREATMENT. BECAUSE IT IS NOT POSSIBLE TO IDENTIFY THOSE PATIENTS IN WHICH TREATMENT WILL RESOLVE THE SYMPTOMS, ALL PATIENTS WITH SYMPTOMS ARE TREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17529 IMMULITE 2000 H. PYLORI IGG IN-VITRO DIAGNOSTIC TEST KIT LYR DIAGNOSTIC PRODUCTS CORP. NA 104

    Patients

    Seq Age Sex Outcome Treatment
    1 *