BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2110398 · Received June 1, 2011

    Report

    Report Number
    2122870-2011-01658
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    April 15, 2011
    Report Date
    May 6, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED ON (B)(6) 2011. THE FIELD SERVICE ENGINEER (FSE) PERFORMED A MAJOR PREVENTIVE MAINTENANCE (PM) ACTIVITY. WHILE PERFORMING THE PM THE FSE DISCOVERED THAT A WASH WHEEL BEARING HAD DETERIORATED SO AS TO PREVENT SYSTEM INITIALIZATION. THE FSE REPLACED THE WORN WASH WHEEL BEARING AND VERIFIED THE INTEGRITY OF THE OTHER BEARINGS. AFTER COMPLETING THE REPAIRS THE FSE RETURNED TO THE CUSTOMER SITE ON (B)(6) 2011 AND REPLACED THE WASH CAROUSEL BEARINGS AND MIXERS. THE FSE OBTAINED LUMINOMETER READ ERRORS. THE FSE ORDERED REPLACEMENT LUMINOMETER PARTS AND PERFORMED LUMINOMETER REPAIRS. THE FSE REPLACED THE LUMINOMETER CONTROL BOARD AND COMPLETED A MINOR PM. A SYSTEM CHECK, QUALITY CONTROL ASSESSMENT AND HIGH SENSITIVITY SYSTEM CHECK WERE PERFORMED TO VERIFY INSTRUMENT PERFORMANCE AND THE RESULTS WERE FOUND TO BE WITHIN INSTRUMENT SPECIFICATIONS. ALTHOUGH THE INSTRUMENT WAS REPAIRED AND RETURNED INTO SERVICE, THE ROOT CAUSE OF THE EVENT HAS NOT BEEN DETERMINED TO DATE.

    Additional Manufacturer Narrative · 1

    THE CLASSIFICATION PRODUCT CODE OF THE SUSPECT MEDICAL DEVICE INVOLVED WAS INCORRECTLY IDENTIFIED AS CGN IN THE ORIGINAL 3500A. THE CORRECT CLASSIFICATION PRODUCT CODE IS JJE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 A CARDIAC TROPONIN (ACCUTNI) RESULT ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) THRESHOLD WAS GENERATED ON THE ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT SAMPLE. THE PATIENT'S ASSOCIATED CREATINE KINASE-MB ISOENZYME (CK-MB) WAS WITHIN NORMAL REFERENCE RANGE. THE ACCUTNI RESULT WAS REPORTED OUT OF THE LABORATORY. THE PATIENT WAS TRANSFERRED TO AN ASSOCIATED HOSPITAL'S CATHETERIZATION LABORATORY BASED UPON THE ERRONEOUSLY ELEVATED ACCUTNI RESULT. A TEST OF A REDRAWN SAMPLE, ON THE SAME INSTRUMENT, GENERATED A LOWER ACCUTNI VALUE WITHIN THE NORMAL REFERENCE RANGE THAT WAS CONSIDERED VALID. QUALITY CONTROL RESULTS WERE PERFORMING WITHIN CUSTOMER ESTABLISHED RANGES AT THE TIME OF THE EVENT AND SYSTEM CHECKS AFTER THE EVENT WERE MEETING ESTABLISHED SPECIFICATIONS. SYSTEM CHECK DATA PRIOR TO THE EVENT WAS NOT SUPPLIED BY THE CUSTOMER. THE CUSTOMER REPORTED THAT SAMPLE HANDLING MAY HAVE CONTRIBUTED TO THE EVENT AS THE INITIAL SAMPLE WAS REFRIGERATED AND A MICRO-CLOT WAS OBSERVED IN IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ACCESS ACCUTNI