BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2253109 · Received September 9, 2011

    Report

    Report Number
    2122870-2011-03429
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    May 8, 2010
    Report Date
    May 10, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES WERE COLLECTED IN 13X100 MM PLASTIC LITHIUM HEPARIN PLASMA TUBES. SAMPLES WERE CENTRIFUGED FOR EIGHT MINUTES AT 3900 AT ROOM TEMPERATURE IN A SWINGING BUCKET CENTRIFUGE. QUALITY CONTROL (QC) WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO AND AFTER THE EVENT. SPECIFIC QC DATA AND SYSTEM INFORMATION WAS NOT SUPPLIED. ON (B)(4) 2010, THE FIELD SERVICE PERFORMED A HIGH SENSITIVITY SYSTEM CHECK WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. PERFORMED A PRECISION TEST USING THE SAMPLES IN QUESTION; ALL TESTING PASSED WITHIN RANGE AND HAD LOW %CV (COEFFICIENT OF VARIATION). THERE WERE NO HARDWARE ISSUES IDENTIFIED. ROOT CAUSE WAS NOT DETERMINED. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4), 2008 AND (B)(4), 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS. THIS MDR REPRESENTS EVENT 1 OF 4 REPORTED BY THIS CUSTOMER. THE RELATED MDRS THAT HAVE BEEN REPORTED ARE: MDR 2122870-2011-03430, MDR 2122870-2011-03431, MDR 2122870-2011-03432.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS HIGH ACCU TNI (TROPONIN 1) TEST RESULTS WERE OBTAINED FOR FOUR PATIENT SAMPLES WHEN USING THE ACCESS 2 IMMUNOASSAY SYSTEM. THE ERRONEOUS HIGH TEST RESULTS WERE ABOVE THE NORMAL REFERENCE RANGE, AND BELOW THE AMI (ACUTE MYOCARDIAL INFARCTION) CUTOFF OF 0.50 NG/ML. TEST RESULTS FOR TWO OF THE FOUR WERE REPORTED OUT OF THE LABORATORY. REPEAT ANALYSIS WAS PERFORMED. THE TEST RESULTS WERE WITHIN THE NORMAL RANGE. NO REPORTS OF DEATH OR SERIOUS INJURY AS A RESULT OF THIS EVENT. THIS IS EVENT 1 OF 4 EVENTS REPORTED BY THE CUSTOMER. THIS MDR IS CONCERNING PATIENT # 1 TESTED ON (B)(6) 2010. THE INITIAL ERRONEOUS TEST RESULTS WERE REPORTED OUT OF THE LABORATORY. AFFECT TO PATIENT TREATMENT IS UNKNOWN.

    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