BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 1242917 · Received November 20, 2008

    Report

    Report Number
    2122870-2008-00379
    Event Type
    Malfunction
    Date Received
    November 20, 2008
    Date of Event
    October 31, 2008
    Report Date
    November 20, 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
    CA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMENS WERE PLASMA COLLECTED IN 7ML LITHIUM HEPARIN TUBES WITH GEL AND WERE CENTRIFUGED AT 3,000 RPM AT ROOM TEMPERATURE FOR 10 MINUTES. PER CUSTOMER, THE SAMPLES WERE ADEQUATELY FULL UPON COLLECTION AND VISUALLY APPEARED "NORMAL". PER CUSTOMER, QC WAS IN RANGE PRIOR TO THE EVENT. A CUSTOMER TECHNICAL SUPPORT (CTS) DID REQUEST TESTING OF QC AND SYSTEM CHECK FOLLOWING THE EVENT. TO DATE, NO UPDATES HAVE BEEN RECEIVED FROM CUSTOMER REGARDING IF THIS TESTING PASSED. THE CUSTOMER INDICATES THEY STOPPED TESTING ON THE SYSTEM FOLLOWING THE ELEVATED RESULT FROM PATIENT C. A FIELD SERVICE ENGINEER (FSE) WAS INITIALLY DISPATCHED; HOWEVER, THE CUSTOMER CALLED BACK TO REQUEST SERVICE BE CANCELLED. THE CUSTOMER INFORMED THEY NEED TO HAVE THEIR TECHNICAL SERVICE DEPARTMENT VERIFY THE HARDWARE FIRST. BASED ON THE CUSTOMER'S UPDATE, THE SERVICE PROVIDED BY THEIR IN-HOUSE ENGINEER HELPED TO RESOLVE THE ISSUE. NO ADDITIONAL DETAILS REGARDING SERVICE WERE SUPPLIED BY THE CUSTOMER. A CLEAR ROOT CAUSE FOR THIS EVENT IS UNKNOWN AT THIS TIME. 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 GENERATED BY THE ACCESS 2 INSTRUMENT FOR THREE PATIENTS. ACCU TNI RESULTS WERE: 0.07NG/ML AND 5.4NG/ML FOR PATIENT A, TWO RESULTS OF 6.6NG/ML FOR PATIENT B, AND 5.6NG/ML FOR PATIENT C. THE RESULTS WERE REPORTED OUT OF THE LAB. THE SAMPLES OF ALL 3 PATIENTS WERE TESTED FOR TROPONIN BY AN ALTERNATE METHOD AND "NORMAL" RESULTS WERE OBTAINED. THERE HAS BEEN NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT RECEIVED TO BCI TO DATE IN ASSOCIATION WITH 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. IMMUNOASSAY SYSTEM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA