BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1982870 · Received February 9, 2011

    Report

    Report Number
    2122870-2011-00348
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    October 8, 2010
    Report Date
    January 12, 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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED IN LITHIUM HEPARIN TUBE AND WAS CENTRIFUGED AT < 5000 RPM FOR 10 MINUTES. THE CUSTOMER IS NOT REPORTING ANY ISSUES WITH QC OR INSTRUMENTATION. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. BCI CUSTOMER PRODUCT LINE SUPPORT (CPLS) IDENTIFIED AN INTERFERENT IN THE PATIENT'S SAMPLE FROM (B)(6) 2011. THE RELATED EVENT IS REPORTED IN MEDWATCH #2122870-2011-00355. A ROOT CAUSE FOR THIS EVENT WAS A PATIENT SOURCE INTERFERENT IN THE SAMPLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) IN REGARDS TO CONSISTENTLY ELEVATED TROPONIN (ACCUTNI) RESULTS ABOVE THE AMI CUTOFF GENERATED BY ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT'S SAMPLE. THE RESULTS WERE REPORTED OUT OF THE LABORATORY, AND WERE QUESTIONED BY THE PHYSICIAN. IT IS UNKNOWN TO THE CUSTOMER WHETHER THERE WAS PATIENT INJURY REQUIRING MEDICAL INTERVENTION 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