BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 1001715 · Received February 15, 2008

    Report

    Report Number
    2122870-2008-00051
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    January 23, 2008
    Report Date
    February 15, 2008
    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
    NH, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON AN ARCHIVED DATA, CUSTOMER EXPERIENCED SEVERAL QC FAILURES IN 2008. QC WAS REPEATED AND RESULTED IN RANGE. QC PERFORMED THE SAME MONTH, PASSED WITHIN THE CUSTOMER'S ESTABLISHED RANGES. A SYSTEM CHECK PERFORMED ON ORIGINAL DATE, WAS WITHIN SPECIFICATIONS. THE SPECIMENS WERE PLASMA TYPE WITH LITHIUM HEPARIN, COLLECTED INTO 13X100 TUBES. THE SAMPLES WERE CENTRIFUGED AT 3,000 RPM FOR 10 MINS AT AMBIENT TEMPERATURE. THE SPECIMENS WERE TESTED WITHIN THE TIME FRAME AS RECOMMENDED IN THE ASSAY INSERT. PER CUSTOMER, NO SAMPLE INTEGRITY ISSUES WERE NOTED WHEN THE SAMPLES WERE OBSERVED VISUALLY. SAMPLE B WAS SENT TO BECKMAN COULTER INC. (BCI) FOR VERIFICATION. THE SAMPLE RECOVERED HIGH AND DID NOT SIGNIFICANTLY REDUCE WITH THE ADDITION OF VARIOUS BLOCKERS. A CLEAR ROOT CAUSE 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 ELEVATED TROPONIN (ACCU TNI) RESULTS THAT WERE GENERATED BY THE ACCESS 2 INSTRUMENT FOR SAMPLES FROM ONE PT. FROM 2008 SEVERAL SAMPLES WERE COLLECTED FROM A PT AND TESTED FOR ACCU TNI: SAMPLE A: ACCU TNI RESULT WAS 3.41NG/ML. SAMPLE B: AN INITIAL ACCU TNI RESULT WAS ">96NG/ML-OVR" AND THE SAME RESULT WAS OBTAINED UPON REPEAT. THE DILUTED SAMPLE 1:10 GAVE A RESULT OF 66.2NG/ML ('OVR-THE CALCULATED CONCENTRATION IS ABOVE THE HIGHEST OR MOST CONCENTRATED CALIBRATOR). THE SAMPLE WAS TESTED FOR TROPONIN ON A DIFFERENT INSTRUMENT IN THE CUSTOMER'S LAB AND A RESULT OF 147NG/ML WAS OBTAINED. SAMPLE C AND D: ACCU TNI RESULTS WERE 69NG/ML AND 22NG/ML RESPECTIVELY. THE CUSTOMER CONFIRMED NO DEATH, INJURY, OR CHANGE TO PT TREATMENT OCCURRED FOR THE PT 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 JJE BECKMAN COULTER, INC. ACCESS 2 IMMUNOASSAY SYSTEM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA