BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 1200166 · Received October 1, 2008

    Report

    Report Number
    2122870-2008-00306
    Event Type
    Other
    Date Received
    October 1, 2008
    Date of Event
    September 5, 2008
    Report Date
    October 1, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    DHA
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WAS SERUM AND SAMPLE PROCESSING INFORMATION WAS ACCORDING TO THE TUBE MANUFACTURER'S RECOMMENDATIONS. QC IS RUN EVERY 8 HOURS AND WAS WITHIN SPECIFICATIONS PRIOR TO THE EVENT. NO ERRORS WERE POSTED TO THE EVENT LOG DURING THE EVENT. A SYSTEM CHECK PERFORMED IN 2008 PASSED SPECIFICATIONS. CUSTOMER RERAN SAMPLES BACK TO THE LAST ACCEPTABLE QC. NO OTHER RESULTS ARE IN QUESTION AT THIS TIME. A FIELD SERVICE ENGINEER (FSE) WAS ON SITE THE SAME DAY: FSE FOUND THAT THE CLOT DETECTION WAS DISABLED. FSE RE-ESTABLISHED THE PRESSURE CURVE AND ENABLED CLOT DETECTION. ULTRASONIC VOLTAGES WERE CHECKED. DIAGNOSTIC TESTING AND QC PASSED SPECIFICATIONS. FSE STATES THAT THE POST-ANALYSIS EXAMINATION SHOWED THAT THE SAMPLE WAS MILDLY HEMOLYZED WITH NO VISIBLE FIBRIN. PER FSE, A POSSIBLE SAMPLE ASPIRATION PROBLEM MAY HAVE CONTRIBUTED TO THIS EVENT. HOWEVER, A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE, A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING AN ERRONEOUS TBHCG RESULTS GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT. A PATIENT SAMPLE WHEN TESTED GAVE TBHCG RESULT OF 0.00MIU/ML. THIS RESULT WAS QUESTIONED BECAUSE IT DID NOT FIT THE PATIENT'S CLINICAL PICTURE. UPON REPEAT, THE SAMPLE GAVE POSITIVE RESULTS OF ">1000.00MIU/ML" AND "34000.00MIU/ML". THE ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. NO REPORTS OF DEATH, INJURY OR CHANGED TO PATIENT TREATMENT HAVE BEEN RECEIVED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER DHA BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA