BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2073485 · Received May 1, 2011

    Report

    Report Number
    2122870-2011-01198
    Event Type
    Malfunction
    Date Received
    May 1, 2011
    Date of Event
    March 31, 2011
    Report Date
    April 1, 2011
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES WERE COLLECTED IN LI HEPARIN PST TUBES AND CENTRIFUGED FOR 3 MINUTES AT 5060 RPM. QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO THE ERRONEOUS ACCUTNI RESULTS AT 9 AM. ERRONEOUS RESULTS OCCURRED AT 2:07 PM THROUGH 11:14 PM. QC WAS OUT OF SPECIFICATIONS, HIGH AT 10:26 PM. BCI FIELD SERVICE ENGINEER (FSE) REMOVED GAUZE FROM THE INCUBATOR TRACK AND ANOTHER ONE THAT WAS CAUGHT IN THE CARD CAGE FAN. FSE FOUND THE ASPIRATE PROBE BENT. FSE REPLACED THE ASPIRATE PROBES ALONG WITH THE SAMPLE PIPETTOR. FSE PERFORMED A PREVENTIVE MAINTENANCE. ALL VERIFICATION TESTING MET SPECIFICATIONS. ALTHOUGH HARDWARE ISSUES WERE ADDRESSED, A DEFINITIVE ROOT CAUSE FOR THIS EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT OBTAINING FALSELY ELEVATED TROPONIN (ACCUTNI) RESULTS ABOVE THE AMI CUTOFF AND WITHIN THE RISK STRATIFICATION RANGE, GENERATED BY THE ACCESS 2 IMMUNOASSAY ANALYZER, FOR FIFTY THREE (53) PATIENTS' SAMPLES. THE RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND THE ER PHYSICIAN QUESTIONED SEVERAL OF THE RESULTS. REPEAT RESULTS OF THESE 53 PATIENTS SAMPLES RESULTED LOWER WITHIN THE RISK STRATIFICATION RANGE AND WITHIN THE NORMAL REFERENCE RANGE. 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 JJE BECKMAN COULTER INC. ACCESS® 2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1