BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 717550 · Received August 31, 2005

    Report

    Report Number
    2122870-2005-00131
    Event Type
    Other
    Date Received
    August 31, 2005
    Date of Event
    August 4, 2005
    Report Date
    August 31, 2005
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    DPZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER REGARDING FALSE NEGATIVE TOTAL BHCG (TBHCG) TEST RESULT FROM A SINGLE PT THAT WAS GENERATED BY THE ACCESS 2 INSTRUMENT. THE CUSTOMER INDICATED THAT THE TBHCG RESULT WAS 1.25MIU/ML. THE RESULT WAS REPORTED OUT OF THE LAB. THE CUSTOMER INDICATED THAT A URINE SAMPLE WAS COLLECTED FROM THE PT AND TESTED FOR TBHCG BY QUALITATIVE METHOD; THE RESULT WAS POSITIVE. THE CUSTOMER INDICATED THAT A NEW BLOOD SAMPLE (#2) WAS COLLECTED FROM THE PT AND TESTED (NEAT) FOR TBHCG; THE RESULT WAS ">1000.00MIU/ML". THE CUSTOMER INDICATED THAT THE SAMPLE #2 WAS RE-TESTED (DILUTION) FOR TBHCG; THE RESULT WAS 23,016.20MIU/ML. THE CUSTOMER THEN REPEATED THE PT'S INITIAL SAMPLE FOR TBHCG; THE RESULT WAS 22,386MIU/ML. IN ADDITION, THE CUSTOMER INDICATED THAT THE PT STATED TO THE CUSTOMER THAT THIS TEST PREVIOUSLY RAN AT ANOTHER FACILITY WAS 13,000 (METHOD, UNITS AND DATE WERE NOT SUPPLIED). THE CUSTOMER INDICATED THAT THERE WAS NO CHANGE IN PT TREATMENT THAT CAN BE ATTRIBUTED TO OR CONNECTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER DPZ BECKMAN COULTER, INC. ACCESS 2 IMMUNOASSAY SYSTEM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA