BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2420895 · Received January 19, 2012

    Report

    Report Number
    2122870-2012-00043
    Event Type
    Injury
    Date Received
    January 19, 2012
    Date of Event
    December 26, 2011
    Report Date
    December 26, 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
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE ON (B)(6) 2011 FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) PERFORMED A HIGH SENSITIVITY SYSTEM CHECK WHICH FAILED TO PASS WITHIN INSTRUMENT SPECIFICATIONS. THE FSE REPLACED THE ASPIRATE PROBE PERI-PUMP TUBING IN ORDER TO GET THE PROBE TO FUNCTION AND ASPIRATE PROPERLY. THE FSE VERIFIED THE REPAIRS BY PERFORMING A SYSTEM CHECK, A HIGH SENSITIVITY SYSTEM CHECK AND A QUALITY CONTROL ASSESSMENT, WHICH ALL GENERATED ACCEPTABLE RESULTS. AFTER THE COMPLETION OF THE NECESSARY AND VERIFIED REPAIRS, THE INSTRUMENT WAS RETURNED BACK INTO OPERATION. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT WITH THE DATA PROVIDED. ASSOCIATED MDRS: 2122870-2012-00043; 2122870-2012-00044.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 HIGHER THAN EXPECTED CARDIAC TROPONIN (ACCUTNI) RESULTS WERE GENERATED FROM AN ACCESS 2 IMMUNOASSAY SYSTEM FOR ELEVEN PATIENTS. ADDITIONAL PATIENT RESULT DATA WAS PROVIDED BY THE CUSTOMER BUT THE RESULTS WERE NOT QUESTIONED BY THE CUSTOMER AND HENCE WERE NOT INCLUDED IN THIS EVENT. THE TREATMENT OF ONE OF THE PATIENTS INVOLVED IN THIS EVENT WAS IMPACTED BY THE HIGHER THAN EXPECTED ACCUTNI RESULT. THIS REPORT IS TO ADDRESS THE INITIAL, HIGHER THAN EXPECTED ACCUTNI RESULT GENERATED ON AN ACCESS 2 IMMUNOASSAY SYSTEM ON (B)(6) 2011 WHICH RESULTED IN THE IMPACT TO ONE PATIENT'S TREATMENT. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED DATA INDICATED THAT THE INITIAL ACCUTNI RESULT WAS WITHIN THE RISK STRATIFICATION RANGE OF THE ASSAY. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AND THE PATIENT WAS ADMITTED TO THE HOSPITAL BASED UPON THE ERRONEOUSLY ELEVATED ACCUTNI RESULT. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED DATA INDICATED THAT THE SAMPLE WAS REPEATED ON ANOTHER INSTRUMENT AND YIELDED A LOWER RESULT, WITHIN THE NORMAL RANGE OF THE ASSAY, WHICH WAS REGARDED AS VALID. THE SAMPLE WAS COLLECTED IN A LITHIUM HEPARIN TUBE AND CENTRIFUGED PRIOR TO TESTING. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED INSTRUMENT ASSAY PERFORMANCE DATA INDICATED THAT A SYSTEM CHECK PERFORMED PRIOR TO THE EVENT HAD PASSED WITHIN INSTRUMENT SPECIFICATIONS. INSTRUMENT ASSAY QUALITY CONTROL RESULTS GENERATED AFTER THE EVENT DID NOT MEET CUSTOMER ESTABLISHED 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 Hospitalization ACCESS ACCUTNI - REAGENT