BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2252933 · Received September 9, 2011

    Report

    Report Number
    2122870-2011-03478
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    May 21, 2010
    Report Date
    May 21, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES INFORMATION WAS NOT PROVIDED. ONE OF THE THREE LEVELS OF QUALITY CONTROL (QC) WAS OUT OF SPECIFICATIONS JUST PRIOR TO THE ERRONEOUS RESULTS. THREE LEVELS OF QC WERE PERFORMED AFTER THE ERRONEOUS RESULTS AND WERE WITHIN THE CUSTOMER'S ESTABLISHED RANGES. SYSTEM MAINTENANCE INFORMATION WAS NOT SUPPLIED. CUSTOMER REPEATS ACCUTNI RESULTS OF 0.06 NG/ML AND GREATER IF THERE IS NO CLINICAL HISTORY. ON (B)(4) 2010, THE FIELD SERVICE ENGINEER REPLACED THE PERI PUMP ASSEMBLY AND PERFORMED A 10 REPETITION PRECISION RUN WITH CARDIAC LOW CONTROL WHICH RESULTED WITH GREAT PRECISION. PERFORMED THE HIGH SENSITIVITY SYSTEM CHECK WHICH MET SPECIFICATIONS. VERIFICATION TESTING WAS PERFORMED AND MET PUBLISHED SPECIFICATIONS. ON (B)(4) 2010, AN APPLICATIONS SPECIALIST WAS SCHEDULED TO WORK WITH THIS CUSTOMER TO REDUCE PRE-ANALYTICAL VARIABLES. 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 2 OF 3 REPORTED BY THIS CUSTOMER. THE RELATED MDR ARE: 2122870-2011-03477, 2122870-2011-03479.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS HIGH ACCU TNI (TROPONIN I) TEST RESULTS WERE OBTAINED FOR THREE 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 WERE REPORTED OUT OF THE LABORATORY FOR ONE OF THE THREE PATIENT SAMPLES. 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 2 OF 3 REPORTED BY THIS CUSTOMER FOR THREE PATIENTS. AFFECT TO PATIENT TREATMENT IS UNKNOWN. TEST RESULTS WERE NOT IDENTIFIED FOR THE PATIENT THAT WAS REPORTED OUT OF THE LABORATORY.

    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