BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2252908 · Received September 9, 2011

    Report

    Report Number
    2122870-2011-03470
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    February 27, 2010
    Report Date
    March 24, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WAS COLLECTED IN 7ML PLASTIC LITHIUM HEPARIN PLASMA TUBE WITH A GEL SEPARATOR. QUALITY CONTROL (QC) WAS WITHIN THE CUSTOMER ESTABLISHED RANGERS PRIOR TO AND AFTER THE EVENT. PERFORMS QC THREE TIMES PER DAY. ROUTINE SYSTEM CHECK WAS PERFORMED ON (B)(6) 2010 WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. THE CUSTOMER PERFORMED A 20 REPLICATE PRECISION RUN AND WAS SATISFIED WITH THE RESULTS. NO OTHER ASSAY OR RESULT IS IN QUESTION. SERVICE WAS OFFERED, BUT WAS DECLINED BY THE CUSTOMER. 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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS HIGH ACCU TNI (TROPONIN I) TEST RESULT WAS OBTAINED FOR ONE PATIENT SAMPLE 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 WERE REPORTED OUT OF THE LABORATORY. THE INITIAL TEST RESULTS WERE QUESTIONED BY THE PHYSICIAN. ANOTHER SAMPLE WAS DRAWN. REPEAT ANALYSIS WAS PERFORMED WITH BOTH SAMPLES. THE TEST RESULTS WERE WITHIN THE NORMAL RANGE. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

    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