BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2639258 · Received July 3, 2012

    Report

    Report Number
    2122870-2012-01567
    Event Type
    Malfunction
    Date Received
    July 3, 2012
    Date of Event
    June 12, 2012
    Report Date
    June 13, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT ONE'S SAMPLE CENTRIFUGATION DID NOT DIRECTLY ALIGN WITH MANUFACTURER RECOMMENDATIONS HOWEVER IT CANNOT BE CONFIRMED THAT THIS WAS A CONTRIBUTING CAUSE TO THIS EVENT. SERVICE WAS DISPATCHED TO THE SITE. THE FIELD SERVICE ENGINEER (FSE) NOTED POOR PRECISION DURING A FIFTY REPETITION PRECISION TEST. THE INSTRUMENT'S TIMING BELT WAS REPLACED. A SUBSEQUENT SUCCESSFUL SYSTEM CHECK WAS PERFORMED AND A TWENTY FIVE REPETITION PRECISION ACCUTNI TEST GENERATED RESULTS WITHIN ASSAY/INSTRUMENT/LABORATORY SPECIFICATIONS. UPON THE COMPLETION OF THE NECESSARY AND VERIFIED REPAIRS, THE INSTRUMENT WAS RETURNED BACK INTO OPERATION. IN CONCLUSION, THE CAUSE FOR THIS EVENT WAS LIKELY THE FAILED TIMING BELT. MDRS ASSOCIATED WITH THIS EVENT: 2122870-2012-01567, 2122870-2012-01568.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN ERRONEOUSLY ELEVATED AND IMPRECISE CARDIAC TROPONIN (ACCUTNI) RESULT, WITHIN THE RISK STRATIFICATION OF THE ASSAY, WAS GENERATED ON AN ACCESS 2 IMMUNOASSAY SYSTEM FOR A SINGLE PATIENT. THE CUSTOMER INDICATED THAT TEN ADDITIONAL PATIENT PRECISION ASSESSMENTS GENERATED ACCEPTABLE AND REPRODUCIBLE RESULTS. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED PRECISION STUDY DATA INDICATED THAT TWO ADDITIONAL PATIENT RESULTS (GENERATED ACROSS TWO DAYS) WERE NON-REPRODUCIBLE. THE REMAINDER OF THE SUPPLIED PRECISION STUDY PATIENT RESULTS WERE FOUND TO BE REPRODUCIBLE. THIS REPORT REPRESENTS THE ERRONEOUS/IMPRECISE ACCUTNI RESULTS, WITHIN THE RISK STRATIFICATION OF THE ASSAY, GENERATED FOR TWO PATIENTS. THE INITIAL ELEVATED ACCUTNI RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO DEATH OR SERIOUS INJURY REPORTED. IT WAS CONFIRMED THAT THERE WAS NO IMPACT TO ONE PATIENT'S TREATMENT, HOWEVER IT IS UNKNOWN AS TO WHETHER THE ERRONEOUS, INITIAL ACCUTNI RESULT GENERATED FOR THE SECOND PATIENT RESULTED IN MODIFICATION TO PATIENT TREATMENT. UPON MULTIPLE REPEAT TESTING ON THE SAME AND/OR AN ALTERNATE INSTRUMENT, REPEAT ACCUTNI RESULTS WERE LOWER, WITHIN THE NORMAL REFERENCE RANGE OF THE ASSAY, AND REGARDED AS VALID FOR BOTH PATIENTS. IT IS KNOWN THAT AN AMENDED REPORT WAS ISSUED FOR PATIENT ONE. ONE PATIENT'S SAMPLE WAS FRESH AND COLLECTED IN A LITHIUM HEPARIN TUBE. THE SAMPLE WAS CENTRIFUGED AT SIX THOUSAND REVOLUTIONS PER MINUTE FOR FIVE MINUTES AT AMBIENT TEMPERATURE. THE SAMPLE WAS STORED REFRIGERATED AND ALIQUOTTED AND RECENTRIFUGED PRIOR TO RETESTING. THERE WERE NO VISIBLE ABNORMALITIES NOTED WITH THE SAMPLE. SAMPLE INFORMATION FOR THE SECOND PATIENT WAS NOT PROVIDED. INSTRUMENT/ASSAY QUALITY CONTROL RESULTS WERE WITHIN CUSTOMER ESTABLISHED SPECIFICATIONS PRIOR TO THE EVENT. THE ACCUTNI REAGENT AND CALIBRATOR LOTS ASSOCIATED WITH THIS EVENT WERE 218227 AND 121451 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