BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 1083922 · Received July 28, 2008

    Report

    Report Number
    2122870-2008-00229
    Event Type
    Malfunction
    Date Received
    July 28, 2008
    Date of Event
    July 3, 2008
    Report Date
    July 28, 2008
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS IN RANGE BEFORE AND AFTER THE EVENT. A SYSTEM CHECK PERFORMED ON 06/24/08 FAILED PARTIALLY AND PASSED UPON REPEAT. PER CUSTOMER, NO ERRORS WERE POSTED TO THE EVENT LOG ON THE DAY OF EVENT. THE SPECIMEN TYPE WAS LITHIUM HEPARIN PLASMA COLLECTED IN A 13 X 100MM BD GEL TUBE AND CENTRIFUGED AT 4,000 RPM FOR 5 MINUTES. PER TUBE MANUFACTURER'S INSERT, THE RECOMMENDED CENTRIFUGE TIME IS 10 MINUTES. THE SPECIMEN SPINNING TIME WAS DISCUSSED WITH THE CUSTOMER. A FIELD SERVICE ENGINEER (FSE) WAS NOT DISPATCHED FOR THIS EVENT AS THE CUSTOMER DECLINED SERVICE. 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 ERRONEOUSLY ELEVATED TROPONIN (ACCU TNI) RESULT GENERATED BY THE ACCESS 2 INSTRUMENT FOR ONE PT. A PT SAMPLE WAS TESTED FOR ACCU TNI AND A RESULT OF 0.55 NG/ML WAS OBTAINED. THE RESULT WAS REPORTED OUT OF THE LAB. ON THE SAME DAY, THE ORIGINAL SAMPLE WAS RE-TESTED TWICE AND TWO RESULTS OF 0.01 NG/ML WERE OBTAINED. THERE HAS BEEN NO REPORT OF DEATH, INJURY, OR CHANGE TO PT TREATMENT AS A RESULT OF 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 IMMUNOASSAY SYSTEM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA