BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2198260 · Received August 9, 2011

    Report

    Report Number
    2122870-2011-02800
    Event Type
    Malfunction
    Date Received
    August 9, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 11, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED IN A GREINER LITHIUM HEPARIN PST PLASMA TUBE WITH A GEL SEPARATOR (THE RECOMMENDED SAMPLE TYPE FOR THIS ASSAY IS SERUM) AND CENTRIFUGED FOR 10 MINUTES AT 3750RPM AT 20°C IN A SWINGING BUCKET CENTRIFUGE. PER CUSTOMER, THE SAMPLE WAS NORMAL IN APPEARANCE, THERE WAS NO DETECTABLE FIBRIN, AND THE DRAW FILLED THE PRIMARY TUBE APPROXIMATELY 75%. SYSTEM CHECK PERFORMED A DAY BEFORE THE EVENT PASSED WITHIN CUSTOMER SPECIFICATIONS. BEC CUSTOMER TECHNICAL SUPPORT (CTS) NOTED THAT SYSTEM CHECK PERFORMED ON (B)(6) 2011 HAD ALL PORTIONS PASSING WITHIN SERVICE SPECIFICATIONS WITH THE EXCEPTION OF THE WASHED PORTION. BOTH LEVELS OF DIGOXIN QC PRIOR TO DISCREPANT RESULT RECOVERED WITHIN RANGE. THIS WAS THE ONLY SAMPLE THAT GAVE A DISCREPANT RESULT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON-SITE (B)(6) 2011 AND PERFORMED A HIGH SENSITIVITY SYSTEM CHECK WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. NO HARDWARE ISSUES WERE NOTED BY THE FSE WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REGARDING A DIGOXIN RESULT ABOVE THE THERAPEUTIC RANGE FOR ONE PATIENT GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM. THE ORIGINAL PATIENT RESULT WAS 3.5NMOL/L (THERAPEUTIC RANGE FOR DIGOXIN: 1.3 -2.6NMOL/L). THIS RESULT WAS NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER RE-RAN THE ORIGINAL SAMPLE NEAT AND IN A 1:2 DILUTION. THE NEAT SAMPLE RECOVERED AT 1.3NMOL/L AND THE 1:2 DILUTION RECOVERED AT 1.1NMOL/L. THE CUSTOMER RE-RAN THE NEAT SAMPLE 4 MORE TIMES AND IT RECOVERED THREE TIMES AT 1.1NMOL/L AND ONCE AT 1.2NMOL/L. THE CUSTOMER DID NOT RESPIN THE SAMPLE BETWEEN RE-RUNS. THE RESULT OF 1.1NMOL/L WAS REPORTED OUT OF LABORATORY. NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED 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 JJE BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1