BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR AFP ASSAY

    MDR report key: 2863552 · Received December 10, 2012

    Report

    Report Number
    1219913-2012-00405
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 10, 2012
    Report Date
    November 11, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LOJ
    PMA / PMN Number
    K020806
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER NOTICED THAT THE ADVIA CENTAUR AFP CALIBRATION AND CONTROLS WERE ERRATIC AND REMOVED THE ADVIA CENTAUR AFP REAGENT PACK FROM THE SYSTEM. THE PARAMAGNETIC PARTICLES WERE NOT SUSPENDED WELL AND THE MATERIAL WAS STUCK ON THE SIDES OF THE REAGENT PACK. THE CUSTOMER DISCONTINUED USING THE SYSTEM. THERE WERE NO ISSUES WITH THE OTHER ASSAYS. A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR SYSTEM INSPECTION. ANOTHER AFP REAGENT PACK WAS INSPECTED AND PLACED ON THE SYSTEM AND THE FSE CHECKED THE CALIBRATION AND CONDUCTED TOTAL SERVICE AND FOUND NO SYSTEM ISSUES. THE SYSTEM WAS OPERATIONAL AND FULLY FUNCTIONAL UPON HIS DEPARTURE. THE CUSTOMER DID NOT REPORT ANY ADDITIONAL DISCORDANT RESULTS. THERE IS NO PATIENT SAMPLE AVAILABLE FOR FURTHER INVESTIGATION. THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR AFP RESULT WAS MOST LIKELY DUE TO A CLUMPY AFP REAGENT PACK. THE INFORMATION FOR USE (IFU) STATES IN THE INTENDED USE SECTION: "WARNING: "USE AFP RESULTS ONLY AS PART OF THE OVERALL CLINICAL EVALUATION OF A PATIENT. DO NOT USE AFP RESULTS AS THE ONLY CRITERION FOR DIAGNOSIS." THE INFORMATION FOR USE (IFU) STATES IN THE LOADING REAGENTS SECTION: "MIX ALL PRIMARY REAGENT PACKS BY HAND BEFORE LOADING THEM ONTO THE SYSTEM. VISUALLY INSPECT THE BOTTOM OF THE REAGENT PACK TO ENSURE THAT ALL PARTICLES ARE DISPERSED AND RESUSPENDED."

    Description of Event or Problem · 1

    A LOW ADVIA CENTAUR XP AFP RESULT WAS OBTAINED ON A PATIENT SAMPLE AND REPORTED TO THE PHYSICIAN. THE LOW RESULTS WERE CONSIDERED DISCORDANT WHEN COMPARED TO REPEAT SAMPLE TESTING. THERE WAS NO REPORT OF PATIENT TREATMENT BEING PRESCRIBED OR ALTERED AND THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP AFP RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR AFP ASSAY AFP IMMUNOASSAY LOJ SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 143

    Patients

    Seq Age Sex Outcome Treatment
    1