BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2644181 · Received July 6, 2012

    Report

    Report Number
    2122870-2012-01566
    Event Type
    Malfunction
    Date Received
    July 6, 2012
    Date of Event
    June 16, 2012
    Report Date
    June 16, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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) NOTED A SUBSTRATE LEAK IN THE WASH CAROUSEL COMING FROM A MALFUNCTIONING SUBSTRATE VALVE. THE FSE REPLACED THE SUBSTRATE VALVE AND CLEANED THE SPILL. A TWENTY REPLICATE ACCUTNI PRECISION TEST WAS PERFORMED ALONG WITH A ROUTINE SYSTEM CHECK AND A HIGH SENSITIVITY SYSTEM CHECK. NO ISSUES WERE NOTED. UPON THE COMPLETION OF THE NECESSARY AND VERIFIED REPAIRS, THE INSTRUMENT WAS RETURNED BACK INTO OPERATION. IN CONCLUSION, THE CAUSE FOR THIS EVENT WAS SUBSTRATE VALVE HARDWARE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ERRONEOUSLY ELEVATED CARDIAC TROPONIN (ACCUTNI) RESULTS, CREATINE KINASE-MB ISOENZYME (CK-MB), AND MYOGLOBIN (MYO) RESULTS WERE GENERATED FROM AN ACCESS 2 IMMUNOASSAY SYSTEM FOR MULTIPLE PATIENTS. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED DATA INDICATED THE INVOLVEMENT OF ELEVEN PATIENTS WITH ELEVATED ACCUTNI, CK-MB AND/OR MYO INITIAL PATIENT RESULTS. UPON REPEAT, ALL PATIENT RESULTS WERE LOWER, IN A DIFFERENT CLINICAL CATEGORY, AND REGARDED AS VALID. THE INITIAL ELEVATED ACCUTNI, CKMB AND MYO RESULT WERE REPORTED OUTSIDE OF THE LABORATORY. THEY WERE QUESTIONED BY A TECHNICIAN. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. THE SAMPLES WERE LITHIUM HEPARIN SAMPLES IN NON GEL, PLASMA TUBES. THE SAMPLES WERE CENTRIFUGED AT AMBIENT TEMPERATURES PRIOR TO TESTING. THE SAMPLES WERE ALIQUOTED OFF AND TESTED FROM THE ALIQUOT TUBES. THE SAMPLES WERE NORMAL IN APPEARANCE WITH NO VISIBLE ABNORMALITIES. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED INSTRUMENT/ASSAY PERFORMANCE DATA INDICATED THAT ALL LEVELS OF ASSAY QUALITY ASSURANCE (QC) RESULTS WERE WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO THE EVENT. HOWEVER, ON THE DAY OF THE EVENT, MYOGLOBIN AND CKMB QC SHOW A SIGNIFICANT SHIFT UP AND OUT OF THE ESTABLISHED RANGE. ALL CALIBRATIONS WERE PASSING AND HAD SATISFACTORY PERCENT COEFFICIENTS OF VARIATION. ROUTINE SYSTEM CHECKS WERE PERFORMED ON 06-11-2012 AND 06-14-2012 AND BOTH PASSED WITHIN INSTRUMENT SPECIFICATIONS. THE ACCUTNI REAGENT AND CALIBRATOR LOTS ASSOCIATED WITH THIS EVENT WERE 012056 AND 116461 RESPECTIVELY. ADDITIONALLY THE CK-MB REAGENT LOT AND MYO REAGENT LOT WERE 123055 AND 120198 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