BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2422489 · Received January 19, 2012

    Report

    Report Number
    2122870-2012-00086
    Event Type
    Injury
    Date Received
    January 19, 2012
    Date of Event
    December 28, 2011
    Report Date
    December 28, 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
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE ON (B)(4) 2011 FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) CLEANED THE ANALYZER'S ANALYTICAL MODULE, AND PERFORMED THE NECESSARY ALIGNMENTS FOR THE INCUBATOR BELT. THE FSE PERFORMED A ROUTINE SYSTEM CHECK AND QUALITY CONTROL ASSESSMENT WHICH BOTH YIELDED RESULTS WERE WITHIN THE EXPECTED RANGES. THE FSE ALSO PERFORMED A TWENTY REPLICATE ACCUTNI PRECISION TEST WHICH PASSED WITHIN THE ASSAY'S EXPECTED PRECISION CLAIMS. AFTER THE COMPLETION OF THE NECESSARY AND VERIFIED REPAIRS, THE INSTRUMENT WAS RETURNED BACK INTO OPERATION. ALTHOUGH PRE-ANALYTICAL FACTORS MAY HAVE BEEN A CONTRIBUTING FACTOR, A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT WITH THE DATA PROVIDED. ASSOCIATED MDRS: 2122870-2012-00086, 2122870-2012-00087.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HIGHER THAN EXPECTED CARDIAC TROPONIN (ACCUTNI) RESULTS, ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) THRESHOLD, WERE GENERATED FROM AN ACCESS 2 IMMUNOASSAY SYSTEM FOR TWO PATIENTS ON TWO DIFFERENT DAYS. THIS IS REPORT ONE OF TWO AND REPRESENTS THE HIGHER THAN EXPECTED CARDIAC TROPONIN (ACCUTNI) RESULT, ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) THRESHOLD, GENERATED ON (B)(6) 2011. BECKMAN COULTER INC ASSESSMENT OF CUSTOMER SUPPLIED DATA INDICATED THAT THE INITIAL ACCUTNI RESULT WAS ABOVE THE AMI THRESHOLD. THE SAMPLE WAS RETESTED ON THE SAME INSTRUMENT WHICH YIELDED A LOWER RESULT, WITHIN THE NORMAL REFERENCE RANGE OF THE ASSAY. THE PATIENT WAS SUBSEQUENTLY REDRAWN AND THE SAMPLE WAS TESTED IN DUPLICATE ON THE SAME INSTRUMENT. BOTH SECOND SAMPLE RESULTS WERE LOWER, WITHIN THE NORMAL REFERENCE RANGE OF THE ASSAY, AND CONCURRED WITH THE ORIGINAL SAMPLE'S REPEAT RESULT. THE ORIGINAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AND THE PATIENT WAS SENT TO THE HEART CATHETERIZATION LAB FOR ADDITIONAL TESTING DUE TO THE FALSELY ELEVATED ACCUTNI RESULT. WHILE IT IS UNKNOWN EXACTLY WHAT PROCEDURE(S) WAS EXECUTED IN THE CATHETERIZATION LABORATORY, PATIENT TREATMENT IS ASSUMED FOR THE PURPOSE OF THIS REPORT. THE SAMPLES WERE COLLECTED IN SERUM TUBES WITH GEL SEPARATORS AND CENTRIFUGED PRIOR TO TESTING. THE ORIGINAL SAMPLE WAS ANALYZED FROM THE PRIMARY TUBE AFTER BEING ALLOWED TO CLOT FOR FIFTEEN MINUTES. BECKMAN COULTER INC LABELING RECOMMENDS A THIRTY MINUTE CLOT TIME. THE SAMPLES WERE NORMAL IN APPEARANCE WITH NO VISIBLE SIGNS OF LIPEMIA, HEMOLYSIS OR CLOTS. BECKMAN COULTER INC ASSESSMENT OF CUSTOMER SUPPLIED INSTRUMENT ASSAY PERFORMANCE DATA INDICATED THAT SYSTEM CHECKS PERFORMED DURING THE TIMEFRAME OF THE EVENT HAD PASSED WITHIN INSTRUMENT SPECIFICATIONS. THERE WERE NO ERRORS IN THE EVENT LOG. INSTRUMENT ASSAY QUALITY CONTROL RESULTS GENERATED ON THE DAY OF THE EVENT MET CUSTOMER ESTABLISHED SPECIFICATIONS. NO OTHER PATIENT ASSAY RESULTS PROVIDED BY THE CUSTOMER WERE QUESTIONED AS PART OF THIS EVENT.

    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 Required Intervention ACCESS ACCUTNI - REAGENT