BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 1991421 · Received February 15, 2011

    Report

    Report Number
    2122870-2011-00356
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 19, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED IN A PLASTIC BD LITHIUM HEPARIN TUBE WITH GEL. THE SAMPLE WAS CENTRIFUGED AT >5000 RPM FRO 5 MINUTES. QC DATA ARE NOT AVAILABLE. CPLS TESTING COULD NOT CONFIRM ANY PATIENT SOURCE INTERFERENT. CPLS TESTED THE RETURNED PATIENT SAMPLE WITH AVAILABLE INTERFERENCE ELIMINATING PROTEINS, BUT THE ACCUTNI DOSE REMAINED AT ~0.9 NG/ML IN EACH CASE. IT APPEARS THAT THE ACCESS RESULTS OBTAINED FOR THE SAMPLES ARE TRUE. SERVICE WAS NOT DISPATCHED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO RECEIVING ACCUTNI RESULT ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUT-OFF FOR ONE PATIENT GENERATED BY ACCESS IMMUNOASSAY ANALYZER. THE RESULT WAS REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE REPEATED ON AN ALTERNATE METHODOLOGY AND NEGATIVE TROPONIN RESULT WAS OBTAINED. SAMPLE WAS SENT TO CUSTOMER PRODUCT LINE SUPPORT (CPLS) FOR ADDITIONAL TESTING AND SIMILAR ACCUTNI RESULTS WERE OBTAINED. THE CUSTOMER DID NOT REPORT AFFECT TO THE 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 MMI BECKMAN COULTER INC. ACCESS 2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1