BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2643095 · Received July 6, 2012

    Report

    Report Number
    2122870-2012-01555
    Event Type
    Malfunction
    Date Received
    July 6, 2012
    Date of Event
    June 11, 2012
    Report Date
    June 11, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT TROPONIN I (ACCUTNI) RERUNS ON THE ACCESS 2 IMMUNOASSAY SYSTEM (ACCESS 2) WERE NOT REPRODUCIBLE AND WAS NOT MATCHING THE RESULTS FROM THE OTHER INSTRUMENT IN THE LABORATORY. CUSTOMER REPORTED THAT ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. CUSTOMER REPORTED THAT PATIENT TREATMENT WAS NOT AFFECTED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. CUSTOMER REPORTED THAT ACCESS ACCUTNI REAGENT, LOT 219417, AND ACCESS ACCUTNI CALIBRATORS (S0-S5), LOT 121451, WERE USED IN CONJUNCTION WITH THE ACCESS 2 SYSTEM. BEC FIELD SERVICE ENGINEER (FSE) PERFORMED REPAIRS TO ADDRESS THE CUSTOMER'S OBSERVATION THAT THE WASH PUMP WAS DEVELOPING BUBBLES IN THE LINES GOING TO THE DISPENSE PROBES. THE FSE REPLACED THE INSTRUMENT WASH VALVE ROTOR/ STATOR ASSEMBLY. THE FSE ALSO CHECKED INSTRUMENT ALIGNMENTS AND ULTRASONICS. THE FSE WAS ABLE TO PRIME THE INSTRUMENT WITHOUT ASPIRATING AIR. THE FSE VERIFIED HARDWARE PERFORMANCE BY COMPLETING A PASSING SYSTEM CHECK AND AN ACCEPTABLE ACCUTNI PRECISION STUDY FOR THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1