BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2323379 · Received October 14, 2011

    Report

    Report Number
    2122870-2011-04549
    Event Type
    Malfunction
    Date Received
    October 14, 2011
    Report Date
    May 24, 2009
    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

    Narratives

    Additional Manufacturer Narrative · 1

    QUALITY CONTROL (QC) AND SYSTEM CHECKS PERFORMED ALL RESULTED WITHIN SPECS. THE CUSTOMER'S BIO-MEDICAL ENGINEER CONTACTED BECKMAN COULTER INC (BCI) CUSTOMER TECH SUPPORT (CTS) ON (B)(4) 2009 TO CONFIRM LUMWASH SON/INC TESTING PASSED. CTS CONFIRMED THE RESULTS MET SPECS. A SYSTEM CHECK AND 20 POINT ACCUTNI PRECISION RUN RESULTED WITHIN SPECS. THE FILED SERVICE ENGINEER WENT ON-SITE ON (B)(4) 2009 AND SPOKE WITH THE BIO-MED ENGINEER. INSTRUMENT VERIFICATION TESTING RESULTS WERE REVIEWED. NO INSTRUMENT ISSUES WERE IDENTIFIED. ROOT CAUSE WAS NOT DETERMINED. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN JAN 1, 2008 AND OCT 23, 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS. THIS IS EVENT 2 OF 3 REPORTED BY THIS CUSTOMER. RELATED MDRS ARE 212287020-2011-04548 AND 04550.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS AND DISCREPANT ACCU TNI (TROPONIN I) TEST RESULTS WERE OBTAINED FOR MULTIPLE PT SAMPLES WHEN USING THE ACCESS 2 IMMUNOASSAY SYSTEM. THE TEST RESULTS WERE DISCREPANT WHEN COMPARED TO TROPONIN I TEST RESULTS OBTAINED USING ANOTHER ACCESS 2 IMMUNOASSAY SYSTEM. THE CUSTOMER DID NOT PROVIDE THE EXACT NUMBER OF PTS INVOLVED. THE CUSTOMER DID PROVIDE TEST RESULTS FOR THREE PT SAMPLES. THE CUSTOMER STATED THAT ERRONEOUS TEST RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO PT TREATMENT AS A RESULT OF THIS EVENT. THIS IS EVENT 2 OF 3 REPORTED BY THIS CUSTOMER FOR THREE DIFFERENT PTS TESTED ON THREE DIFFERENT DATES. THE EXACT DATE OF TESTING IS UNK. AN MDR WAS FILED FOR EACH OF THE THREE PTS.

    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