BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY ANALYZER

    MDR report key: 2223753 · Received August 25, 2011

    Report

    Report Number
    2122870-2011-03117
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    July 26, 2011
    Report Date
    July 27, 2011
    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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED IN A BECTON DICKINSON GEL SEPARATOR TUBE. THE CUSTOMER STATED THAT QC HAD BEEN WORKING WELL RECENTLY. SERVICE WAS DISPATCHED FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) PERFORMED HIGH SENSITIVITY SYSTEM CHECK, WHICH PASSED THE SPECIFICATIONS. SYSTEM CHECK SUBSTRATE RATIO FAILED. THE FSE RESOLVED THE ISSUE BY CLEANING ASPIRATE PROBES. SYSTEM RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. ALTHOUGH HARDWARE ISSUES WERE ADDRESSED BY THE ENGINEER, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) CONCERNING AN ERRONEOUSLY HIGH TROPONIN (ACCUTNI) RESULT WITHIN THE RISK STRATIFICATION RANGE GENERATED BY ACCESS® 2 IMMUNOASSAY ANALYZER FOR ONE PATIENT'S SAMPLE. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. REPEAT TESTING PRODUCED RESULTS WITHIN THE NORMAL REFERENCE RANGE. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1