BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2006582 · Received March 3, 2011

    Report

    Report Number
    2122870-2011-00568
    Event Type
    Malfunction
    Date Received
    March 3, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 1, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS LITHIUM HEPARIN PLASMA THAT WAS CENTRIFUGED FOR 10-12 MINUTES AT 2700 RPM. A SYSTEM CHECK WAS PERFORMED ON (B)(4) 2011 AND MET THE SPECIFICATIONS. QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES. SERVICE WAS ON SITE ON (B)(4) 2011. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE WASH MANIFOLD DUE TO CRACKS AROUND THE VALVE. ALTHOUGH HARDWARE ISSUES WERE ADDRESSED, NO DEFINITIVE ROOT CAUSE FOR THIS EVENT COULD BE DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) IN REGARDS TO AN INCONSISTENT TROPONIN (ACCUTNI) RESULT ABOVE THE AMI CUTOFF GENERATED BY ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT'S SAMPLE. REPEAT TESTING BY AN ALTERNATE METHOD PRODUCED A RESULT ABOVE THE AMI CUTOFF. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO 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. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1