BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LXI ACCESS® 2I IMMUNOASSAY CLINICAL SYSTEM

    MDR report key: 1820005 · Received August 30, 2010

    Report

    Report Number
    2122870-2010-00485
    Event Type
    Malfunction
    Date Received
    August 30, 2010
    Date of Event
    July 31, 2010
    Report Date
    August 30, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023049
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE COLLECTED IN LI HEPARIN TUBE AND IN SERUM TUBE. THEY WERE CENTRIFUGED FOR 3 MINUTES AT 5000 RPM AND 10 MINUTES AT 3600 RPM, RESPECTIVELY. PER CUSTOMER, THE RESULTS OF QC RUNS WERE WITHIN THE CUSTOMER'S ESTABLISHED RANGES. A SYSTEM CHECK WAS PERFORMED ON (B)(4) 2010 AND MET SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS ON SITE ON (B)(4) 2010 AND PERFORMED HARDWARE VERIFICATION PROCEDURE. ALL VERIFICATION TESTING MET PUBLISHED SPECIFICATIONS, AND NO HARDWARE ISSUE WAS NOTED. NO DEFINITIVE ROOT CAUSE FOR THE EVENT HAS BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) IN REGARDS TO ERRONEOUS TROPONIN (ACCUTNI) RESULTS GENERATED ON ACCESS 2I IMMUNOASSAY SYSTEM FOR SEVERAL SAMPLES FROM ONE PATIENT. THE RESULTS WERE WITHIN DIFFERENT CLINICAL RANGES AND WERE NOT REPORTED OUTSIDE THE LABORATORY. NO DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAS BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LXI ACCESS® 2I IMMUNOASSAY CLINICAL SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR