BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2210820 · Received August 12, 2011

    Report

    Report Number
    2122870-2011-02919
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 14, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT PROVIDE INFORMATION INDICATING AN INCREASE IN OCCURRENCE OR AN INSTRUMENT MALFUNCTION. ON-SITE SERVICE NOT NEEDED. THE CUSTOMER WAS REQUESTED TO PROVIDE SPECIFIC DATA, HOWEVER, THE CUSTOMER DECLINED TO PROVIDE THIS INFORMATION. PER CUSTOMER, THE UNIT IS PERFORMING WITHIN QC SPECIFICATIONS. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS EVENT.

    Description of Event or Problem · 1

    BECKMAN COULTER INC. (BCI) CONTACTED THIS CUSTOMER ON (B)(6) 2011 VIA THE TROPONIN (ACCUTNI) MARKETING SURVEY PROGRAM (MSP) CUSTOMER CONTACT PROGRAM. THE CUSTOMER INDICATED SOME OCCURRENCES OF NON-REPRODUCIBLE FALSE POSITIVE ACCUTNI PATIENT RESULTS. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. ACTUAL DATA FOR THESE EVENTS WAS NOT SUPPLIED. THE CUSTOMER PROVIDED INFORMATION THAT THEY HAVE A PROACTIVE PROCEDURE IMPLEMENTED TO VERIFY UNEXPECTED RESULTS PRIOR TO REPORTING RESULT OUTSIDE THE LABORATORY. THE LABORATORY PROCEDURE IS SUMMARIZED AS FOLLOWS: THE LABORATORY HAS A POLICY IN PLACE FOR REPEATING ANY MALE TROPONIN RESULTS OF 0.1 NG/ML OR HIGHER AND REPEATING FEMALES 0.06 NG/ML OR HIGHER. THE PROTOCOL IS TO FILTER ALL SAMPLES THAT ARE HIGHER THAN THEIR CUT-OFF TO REDUCE THE AMOUNT OF FIBRIN IN THE SAMPLES. THE CUSTOMER DID NOT REPORT AFFECT TO PATIENTS ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1