BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2001925 · Received February 27, 2011

    Report

    Report Number
    2122870-2011-00478
    Event Type
    Injury
    Date Received
    February 27, 2011
    Date of Event
    January 31, 2011
    Report Date
    January 31, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED IN A PLASTIC BD LITHIUM HEPARIN PLASMA TUBE. PER CUSTOMER, THE SAMPLE WAS ICTERIC (BILIRUBIN RESULT OF 4.7MG/DL). ACCUTNI QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES FOR THE PAST 30 DAYS. THE CUSTOMER SENT PATIENT SAMPLE TO CUSTOMER PRODUCT LINE SUPPORT (CPLS) FOR ADDITIONAL TESTING. CPLS WAS UNABLE TO REPRODUCE THE CUSTOMER'S ELEVATED VALUES AND WAS ALSO UNABLE TO IDENTIFY HETEROPHILE INTERFERENCE. SERVICE WAS NOT DISPATCHED FOR THIS EVENT AS THE CUSTOMER IS NOT QUESTIONING INSTRUMENT PERFORMANCE AT THIS TIME. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING REPRODUCIBLE ELEVATED TROPONIN (ACCUTNI) RESULTS, WITHIN THE RISK STRATIFICATION RANGE, GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT. THE RESULTS WERE NOT REPORTED OUT OF THE LAB. SUBSEQUENT TESTING ON AN ALTERNATE METHODOLOGY PRODUCED DISCORDANT, LOWER RESULT WITHIN THE NORMAL REFERENCE RANGE. THE RESULT WAS REPORTED OUT OF THE LAB. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF 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. ACCESS® 2 IMMUNOASSAY SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR