BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2003449 · Received March 1, 2011

    Report

    Report Number
    2122870-2011-00468
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    January 31, 2011
    Report Date
    February 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 LI HEPARIN PLASMA WITH A GEL BARRIER THAT WERE CENTRIFUGED FOR 4 MINUTES AT 3800RPM. QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO AND AFTER THE EVENT. A SYSTEM CHECK PERFORMED ON (B)(6) 2011 MET SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS ON-SITE (B)(4) 2011 AND FOUND FLATTENED PERI PUMP TUBING WHILE PERFORMING A MINOR PREVENTIVE MAINTENANCE (PM). ALL VERIFICATION TESTING MET SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRATIC TROPONIN (ACCUTNI) RESULTS GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM FOR TWO PATIENTS' SAMPLES. 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. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1