BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2497584 · Received March 20, 2012

    Report

    Report Number
    2122870-2012-00797
    Event Type
    Injury
    Date Received
    March 20, 2012
    Date of Event
    March 1, 2012
    Report Date
    March 1, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE ON (B)(4) 2012 FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) OBSERVED SOME ELEVATED SYSTEM CHECK RESULTS ON THE DATE OF SERVICE. THE FSE REPLACED THE PERI-PUMP AND THE TRANSDUCER. UPON COMPLETION OF THE NECESSARY REPAIRS, THE INSTRUMENT WAS RETURNED BACK INTO OPERATION. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN ERRONEOUS ELEVATED CARDIAC TROPONIN (ACCUTNI) RESULT, ABOVE THE ASSAY'S ACUTE MYOCARDIAL INFARCTION (AMI) THRESHOLD, WAS GENERATED FROM AN ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT. BECKMAN COULTER INC ASSESSMENT OF CUSTOMER SUPPLIED DATA INDICATED THAT UPON REPEAT TESTING OF THE INITIAL SAMPLE, AS WELL AS REDRAW AND TESTING OF A SECOND, SAME-PATIENT SAMPLE ON THE INSTRUMENT; THE ACCUTNI RESULTS WERE LOWER, WITHIN THE RISK STRATIFICATION RANGE OF THE ASSAY, AND CONSIDERED VALID. AN AMENDED REPORT WAS ISSUED. THE CUSTOMER PROVIDED ADDITIONAL PATIENT CREATINE KINASE-MB ISOENZYME RESULTS FOR THIS PATIENT, HOWEVER, THESE RESULTS WERE REGARDED AS NORMAL BY THE CUSTOMER. THE INITIAL, ELEVATED ACCUTNI RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AND THE PATIENT WAS TREATED WITH LEVONOX AND ASPIRIN AFTER THE ERRONEOUS RESULT WAS OBTAINED. THE SAMPLES WERE COLLECTED IN LITHIUM HEPARIN PLASTIC TUBES. THE SAMPLES WERE NORMAL IN APPEARANCE WITH NO VISIBLE ABNORMALITIES. ASSAY QUALITY CONTROL VALUES RECOVERED WITHIN THE CUSTOMER'S ESTABLISHED SPECIFICATIONS ON THE DATE OF THE EVENT. A SYSTEM CHECK GENERATED RESULTS WHICH MET INSTRUMENT SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention ACCESS ACCUTNI - REAGENT