BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2740382 · Received September 11, 2012

    Report

    Report Number
    2122870-2012-01751
    Event Type
    Malfunction
    Date Received
    September 11, 2012
    Date of Event
    August 22, 2012
    Report Date
    August 22, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE WASH PUMP AND WASH PUMP COMPONENTS TO RESOLVE SYSTEM PERFORMANCE ISSUES. THE FSE VERIFIED INSTRUMENT PERFORMANCE WAS ACCEPTABLE AFTER THE REPAIRS WERE COMPLETED. UPON THE COMPLETION OF THE NECESSARY AND VERIFIED REPAIRS, THE INSTRUMENT WAS RETURNED BACK INTO OPERATION. IN CONCLUSION, HARDWARE IS THE CAUSE OF THIS EVENT. ASSOCIATED MDRS: 2122870-2012-01751, 2122870-2012-01752, 2122870-2012-01753.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ERRONEOUS ELEVATED CARDIAC TROPONIN (ACCUTNI) AND CREATINE KINASE-MB ISOENZYME (CK-MB) RESULTS WERE GENERATED ON AN ACCESS 2 IMMUNOASSAY SYSTEM FOR THREE PATIENTS ON A SINGLE DAY. IT WAS NOT POSSIBLE TO DETERMINE WHICH PATIENT CORRELATED TO THEIR CORRESPONDING RESULTS FROM THE SUPPLIED CUSTOMER PATIENT DATA. THIS REPORT REPRESENTS THE ELEVATED CK-MB AND ACCUTNI RESULTS GENERATED FOR ONE PATIENT. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED DATA INDICATED THE GENERATION OF AN INITIAL ACCUTNI RESULT, ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) THRESHOLD OF THE ASSAY, AND AN ELEVATED CK-MB RESULT ABOVE THE NORMAL REFERENCE RANGE OF THE ASSAY. UPON REPEAT OF THE PATIENT SAMPLE ON AN ALTERNATE INSTRUMENT, LOWER ACCUTNI AND CK-MB RESULTS, WITHIN THE NORMAL REFERENCE RANGE OF THE ASSAY, WERE GENERATED. THIS PATIENT'S INITIAL ERRONEOUS/IMPRECISE ACCUTNI AND CK-MB RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY HOWEVER THERE WAS NO DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE SAMPLE WAS A HEPARINIZED PLASMA SAMPLE WHICH WAS CENTRIFUGED FOR FIVE MINUTES AT FOUR THOUSAND REVOLUTIONS PER MINUTE. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED INSTRUMENT/ASSAY PERFORMANCE DATA INDICATED THAT SYSTEM CHECK DATA FROM (B)(6) 2012 WAS PASSING WITHIN INSTRUMENT SPECIFICATIONS, HOWEVER, SYSTEM CHECKS PERFORMED ON (B)(6) 2012 (AFTER THE ERRONEOUS RESULTS WERE GENERATED) WERE FAILING. THE CUSTOMER INDICATED QUALITY CONTROL (QC) WAS PERFORMING WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO THE EVENT AND THAT QC WAS ALSO PERFORMING WITHIN THE CUSTOMER'S ESTABLISHED RANGES AFTER THE EVENT WITH THE EXCEPTION OF LEVEL ONE ACCUTNI QC. THE ACCUTNI AND CK-MB REAGENT LOTS ASSOCIATED WITH THIS EVENT WERE 220592 AND 220390 RESPECTIVELY.

    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