BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2736371 · Received September 8, 2012

    Report

    Report Number
    2122870-2012-01740
    Event Type
    Malfunction
    Date Received
    September 8, 2012
    Date of Event
    August 17, 2012
    Report Date
    August 21, 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

    SERVICE WAS DISPATCHED TO THE SITE FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) DISCOVERED THAT THE PERI-PUMP TUBING WAS FLATTENED. THE FSE REPLACED THE TUBING, PROBE, MIXERS AND INCUBATOR BELT. THE FSE THEN PERFORMED A ROUTINE SYSTEM CHECK, QUALITY CONTROL ASSESSMENT AND A HIGH SENSITIVITY SYSTEM CHECK WITH ISSUES WERE NOTED. UPON THE COMPLETION OF THE NECESSARY AND VERIFIED REPAIRS, THE INSTRUMENT WAS RETURNED BACK INTO OPERATION. IN CONCLUSION, THE PERI-PUMP TUBING IS THE CAUSE OF THIS EVENT.

    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 A SINGLE PATIENT'S SAMPLE. 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 (SEVERAL DAYS LATER) ON AN ALTERNATE INSTRUMENT, MULTIPLE REPEAT ACCUTNI RESULTS WERE GENERATED WHICH WERE LOWER AND WITHIN THE NORMAL REFERENCE RANGE OF THE ASSAY. A LOWER REPEAT CK-MB RESULT, STILL ABOVE THE NORMAL REFERENCE RANGE FOR THE ASSAY, WAS ALSO GENERATED. COLLECTIVELY THE CK-MB RESULTS EXCEEDED THE ASSAY'S STATED PRECISION CLAIM. THE INITIAL ERRONEOUS/IMPRECISE ACCUTNI AND CK-MB RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT UNDERWENT BOTH A STRESS TEST AND AN ECHOCARDIOGRAM. THE CARDIOLOGIST STATED THAT BOTH RESULTS WERE NEGATIVE AND THAT NO CARDIAC ISSUES WERE IDENTIFIED. THERE WAS NO DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT. THE SAMPLE WAS A LITHIUM HEPARIN PLASMA TUBE CENTRIFUGED FOR FIVE MINUTES AT THREE THOUSAND REVOLUTIONS PER MINUTE. THE CUSTOMER NOTED THAT THE SAMPLE WAS NORMAL AND CLEAR IN APPEARANCE. THE SAMPLE WAS ORIGINALLY SAMPLED AND ANALYZED FROM THE PRIMARY TUBE. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED INSTRUMENT/ASSAY PERFORMANCE DATA INDICATED THAT ALL THREE LEVELS OF THE CUSTOMER'S QUALITY CONTROL RESULTS WERE PERFORMING WITHIN THE LABORATORY'S ESTABLISHED RANGES FOR THE TIMEFRAME OF THE EVENT. CALIBRATION AND ROUTINE SYSTEM CHECK RESULTS GENERATED PRIOR TO THE EVENT WERE ACCEPTABLE. THERE WERE NO ERRORS POSTED TO THE EVENT LOG IN CONJUNCTION WITH THIS EVENT. THE ACCUTNI AND CK-MB REAGENT LOTS ASSOCIATED WITH THIS EVENT WERE 218279 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