BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2761351 · Received September 26, 2012

    Report

    Report Number
    2122870-2012-01778
    Event Type
    Injury
    Date Received
    September 26, 2012
    Date of Event
    September 2, 2012
    Report Date
    September 4, 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
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE PERFORMING PREVENTIVE MAINTENANCE (PM), THE FIELD SERVICE ENGINEER (FSE) DISCOVERED THE INTERNAL VACUUM CHAMBER WAS HALF FULL OF FLUID AND REMOVED THE FLUID. THE FSE NOTED THE END OF THE PERISTALTIC WASTE TUBING WAS LOOSE CAUSING FLUID TO FILL THE VACUUM CHAMBER AND TIGHTENED THE CONNECTOR TO RESOLVE THE ISSUE. AS PART OF PREVENTIVE MAINTENANCE, THE FSE REPLACED THE PIPETTOR TIP, ADJUSTED THE TIP HORIZONTALLY, AND VERIFIED ALIGNMENT. THE FSE ALSO COMPLETED THERMAL, INCUBATOR BELT, AND CASSETTE SYSTEM MODIFICATIONS. SYSTEM CHECK AND HIGH SENSITIVITY SYSTEM CHECK PASSED WITH SPECIFICATIONS. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS. THE PATIENT SAMPLES WERE LITHIUM HEPARIN AND ANALYZED FROM THE PRIMARY TUBE. SAMPLE CENTRIFUGATION WAS PERFORMED AT 5,000 RPM (REVOLUTIONS PER MINUTE) FOR FIVE MINUTES AT ROOM TEMPERATURE. THE CUSTOMER REANALYZED THREE OTHER INITIAL SAMPLES, COLLECTED FROM THE SAME PATIENT, AND ALL PRODUCED NEGATIVE CARDIAC RESULTS. THE CUSTOMER STATED QUALITY CONTROL (QC) WAS ACCEPTABLE AT THE TIME OF THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUSLY ELEVATED TROPONIN I (ACCESS ACCUTNI) RESULT, ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) LIMIT, AND AN ERRONEOUSLY ELEVATED CREATINE KINASE-MB (CK-MB) RESULT, ABOVE THE NORMAL REFERENCE RANGE, FOR ONE PATIENT INVOLVING THE ACCESS 2 IMMUNOASSAY SYSTEM. THE INITIAL RESULTS OBTAINED WERE AS FOLLOWS: 0.61 NG/ML FOR ACCUTNI AND 12.1 NG/ML FOR CK-MB. DUE TO THE ELEVATED RESULTS, THE PATIENT WAS ADMITTED TO THE HOSPITAL AND AN UNKNOWN TREATMENT WAS ADMINISTERED. THERE HAS BEEN NO REPORT OF CURRENT PATIENT OUTCOME. THE PATIENT HAD ANOTHER SAMPLE COLLECTION SIX HOURS LATER, AND THE FOLLOWING CARDIAC TEST RESULTS WERE OBTAINED: 0.00 NG/ML FOR ACCUTNI AND 1.3 NG/ML FOR CK-MB. DUE TO THE DISCREPANT RESULTS, THE CUSTOMER REANALYZED THE ORIGINAL SAMPLE ON AN ALTERNATE ACCESS 2 SYSTEM AND OBTAINED VALUES OF 0.00 NG/ML FOR ACCUTNI AND 1.2 NG/ML FOR CK-MB. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) ASSESSED THE INSTRUMENT AT THE FACILITY.

    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 66 YR Hospitalization| O