BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1972162 · Received January 27, 2011

    Report

    Report Number
    2122870-2011-00157
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    January 2, 2011
    Report Date
    January 3, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS SERUM THAT WAS ALLOWED TO CLOT FOR 20 MINUTES AND CENTRIFUGED FOR 6 MINUTES AT 3600 RPM. PER THE CUSTOMER, THE SAMPLE APPEARED NORMAL. ALL SAMPLES WITH ELEVATED ACCUTNI RESULTS ARE INSPECTED FOR FIBRIN AND RE-CENTRIFUGED PRIOR TO REPEAT ANALYSIS. PER CUSTOMER NOTES, THE ACCUTNI QC RESULTS HAVE BEEN RECOVERING ERRATICALLY LOW. A SYSTEM CHECK WAS PERFORMED ON (B)(4) 2010 AND BOTH MET SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011 FOR THIS EVENT. THE FSE MADE AN ADJUSTMENT TO THE MIXER SPEED AND REPLACED THE SAMPLE PIPETTOR. ALL VERIFICATION TESTING WAS PERFORMED AND MET SPECIFICATIONS. ALTHOUGH HARDWARE ISSUES WERE ADDRESSED, NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING AN ERRONEOUS TROPONIN (ACCUTNI) RESULT WITHIN THE RISK STRATIFICATION RANGE FOR ONE PATIENT'S SAMPLE THAT WAS GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM. UPON REPEAT TESTING, ON AN ALTERNATE SYSTEM, REPRODUCIBLE RESULTS WERE RECOVERED ABOVE THE AMI CUTOFF. NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER INC. ACCESS 2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR