BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1003404 · Received February 21, 2008

    Report

    Report Number
    2122870-2008-00060
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    January 18, 2008
    Report Date
    February 21, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922826
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS PERFORMED PRIOR TO AND AFTER THE EVENT, BUT ACTUAL QC DATA HAS NOT BEEN PROVIDED. THE ANALYZER WAS CURRENTLY PERFORMING WITHIN QC SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS NOT DISPATCHED TO THE CUSTOMER'S LAB. THE CUSTOMER IS SENDING SAMPLES FROM THE FIVE PTS TO BCI FOR INVESTIGATION. HOWEVER, THE SAMPLES HAVE NOT BEEN RECEIVED BY BCI TO DATE. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ELEVATED TROPONIN (ACCU TNI) RESULTS THAT WERE GENERATED BY THE ACCESS IMMUNOASSAY SYSTEM. CUSTOMER REPORTED THAT FALSELY ELEVATED ACCU TNI RESULTS WERE REPORTED OUT OF THE LAB FOR FIVE (5) PTS. THE LAB LATER DISCOVERED THROUGH FURTHER TESTING AND TESTING USING OTHER METHODS THAT THE CORRECT RESULTS FOR THESE PTS WERE NOT ELEVATED. PER CUSTOMER, THE SAMPLES WERE RE-TESTED ON THE ACCESS INSTRUMENT AND ACCU TNI RESULTS WERE REPEATING. THE EXACT PT RESULTS WERE NOT SUPPLIED BY THE CUSTOMER. BASED ON AVAILABLE INFO, THERE WAS CHANGE IN PT TREATMENT; HOWEVER, DETAILS WERE NOT PROVIDED. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PT INJURY REQUIRING MEDICAL INTERVENTION ATTRIBUTED OR CONNECTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. ACCESS IMMUNOASSAY SYSTEM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA