BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2921347 · Received January 17, 2013

    Report

    Report Number
    2122870-2013-00035
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 20, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE CUSTOMER RESOLVED THE ISSUE THROUGH SYSTEM TROUBLESHOOTING. ALL RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS INCIDENT: 2122870-2013-00035, 2122870-2013-00036, 2122870-2013-00037, 2122870-2013-00038, 2122870-2013-00039, 2122870-2013-00040.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED SUPPRESSED TROPONIN I (ACCESS ACCUTNI) AND CREATINE KINASE-MB (CK-MB) RESULTS, FOR MULTIPLE PATIENTS, ON SEPARATE DAYS, INVOLVING THE ACCESS 2 IMMUNOASSAY SYSTEM. THE SUPPRESSED RESULTS WERE DISPLAYED AS NO VALUE OR CANCELLED. THE CUSTOMER ALSO NOTED SAMPLE COUNTS OUTSIDE LIMITS SYSTEM ERROR WITH TROPONIN I RESULTS AND RELATIVE LIGHT UNITS (RLU'S) FLAGS. TROUBLESHOOTING REVEALED ONE OF THE FITTINGS, ON TOP OF THE SUBSTRATE BOTTLE CAP, WAS LOOSE. THE CUSTOMER TIGHTENED THE FITTING AND PRIMED THE INSTRUMENT FOR ALL FLUIDICS. THE CUSTOMER PERFORMED TROPONIN I CONTROLS AND NOTED NO SYSTEM ERRORS OCCURRED. NO ERRONEOUS RESULTS WERE RELEASED OUT OF THE LABORATORY. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. THE CUSTOMER RESOLVED THE ISSUE AND RETURNED THE INSTRUMENT TO NORMAL OPERATION. THIS IS REPORT ONE OF SIX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27134 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1