BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2013587 · Received March 10, 2011

    Report

    Report Number
    2122870-2011-00620
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 8, 2011
    Report Date
    February 8, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS DRAWN INTO PLASTIC 3 ML BD LITHIUM HEPARIN TUBE WITH GEL AND CENTRIFUGED AT 4000 RPM FOR 10 MINUTES AT ROOM TEMPERATURE. THE CUSTOMER NOTED THAT THE PATIENT SAMPLE WAS CENTRIFUGED, ALIQUOTED, AND THEN CENTRIFUGED AGAIN. PER THE CUSTOMER, THE THREE LEVELS OF ACCUTNI QC RESULTED WITHIN THE CUSTOMER'S ESTABLISHED RANGES ON THE DAY OF THE EVENT. SYSTEM CHECKS WERE PERFORMED ON (B)(6) 2011 AND (B)(6) 2011, WHICH RESULTED WITHIN SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(6) 2011 AND PERFORMED A PREVENTIVE MAINTENANCE (PM) WHICH WAS DUE ON (B)(6) 2011. THE FSE ALSO PERFORMED A SYSTEM CHECK AND A PERFORMANCE TEST WHICH ALL MET SPECIFICATIONS. A ROOT CAUSE FOR THIS EVENT WAS NOT DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING AN ERRONEOUSLY HIGH TROPONIN (ACCUTNI) RESULT ABOVE THE AMI CUT-OFF ON ONE PATIENT SAMPLE THAT WAS GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM. RESULTS WITHIN THE NORMAL REFERENCE RANGE WERE OBTAINED UPON REPEAT ANALYSIS. THE ERRONEOUS RESULT WAS NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER DID NOT REPORT AFFECT TO PATIENT OR USER 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 JJE BECKMAN COULTER INC. ACCESS 2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR