BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2261540 · Received September 2, 2011

    Report

    Report Number
    2122870-2011-03321
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    March 14, 2010
    Report Date
    March 15, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES WERE LITHIUM HEPARIN COLLECTED IN PLASMA SEPARATION TUBES. SAMPLES CENTRIFUGED FOR 5 MINUTES FOR 5400. SAMPLES WERE HEMOLYZED. QUALITY CONTROL (QC) WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO AND AFTER THE ERRONEOUS RESULT. A SYSTEM CHECK WAS PERFORMED ON (B)(6) 2010 AND BOTH MET SPECIFICATIONS. A PRECISION RUN USING THE PT'S SECOND SAMPLE WAS WELL WITHIN SPECIFICATIONS. SERVICE WAS OFFERED AND DECLINED BY THE CUSTOMER. CUSTOMER INDICATED THAT THE ISSUE IS SAMPLE HANDLING BECAUSE THE SYSTEM CHECK, CARRYOVER TEST AND THE QC ALL PASSED. ROOT CAUSE WAS NOT DETERMINED. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN JANUARY 01, 2008 AND OCTOBER 23, 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS. THIS MDR REPRESENTS EVENT 1 OF 2 REPORTED BY THIS CUSTOMER. THE RELATED MDR IS 2122870-2011-03322.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS HIGH ACCU TNI (TROPONIN I) TEST RESULT WAS FOR ONE PT SAMPLE WHEN USING THE ACCESS 2 IMMUNOASSAY SYSTEM. THE INITIAL TEST RESULTS WERE ABOVE THE NORMAL REFERENCE RANGE, AND BELOW THE AMI (ACUTE MYOCARDIAL INFARCTION) CUTOFF OF 0.50 NG/ML. THE TEST RESULTS WERE REPORTED OUT OF THE LAB. PHYSICIAN QUESTIONED THE RESULTS AND THE PT WAS REDRAWN. REPEAT ANALYSIS WAS PERFORMED ON THE SAME ACCESS 2 IMMUNOASSAY SYSTEM AND ANOTHER ACCESS 2 IMMUNOASSAY SYSTEM. THE TEST RESULTS WERE WITHIN THE NORMAL RANGE. IT IS UNK IF THERE WAS ANY AFFECT TO PT TREATMENT. NO REPORTS OF DEATH OR SERIOUS INJURY AS A RESULT OF THIS EVENT. THIS IS EVENT 1 OF 2 REPORTED BY THIS CUSTOMER. ERRONEOUS HIGH TROPONIN TEST RESULTS WERE OBTAINED WITH TWO DIFFERENT ANALYZERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS 2 IMMUNOASSAY SYSTEM JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCESS ACCU TNI