BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM, REFURBISHED

    MDR report key: 2430903 · Received January 30, 2012

    Report

    Report Number
    2122870-2012-00196
    Event Type
    Injury
    Date Received
    January 30, 2012
    Date of Event
    October 14, 2011
    Report Date
    December 29, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT SAMPLE WAS COLLECTED IN A SERUM SAMPLE TUBE AND CENTRIFUGED FOR 10 MINUTES AT AN UNSPECIFIED SPEED. QC WAS PERFORMING WITHIN THE CUSTOMER'S ESTABLISHED LIMITS ON THE DATE OF THE EVENT. PER THE CUSTOMER SUPPLIED DOCUMENTATION, SYSTEM CHECKS PERFORMED ON (B)(6) 2011 PASSED WITHIN THE INSTRUMENT SPECIFICATIONS. THE PATIENT SAMPLE WAS SENT TO BEC CUSTOMER PRODUCT LINE SUPPORT (CPLS) FOR ADDITIONAL TESTING: BEC WAS ABLE TO CONFIRM THE CUSTOMER'S FREE T3 AND FREE T4 RESULTS ON UNDILUTED SAMPLE. HETEROPHILE TESTING DID NOT DETECT INTERFERENCE SINCE NONE OF THE BLOCKERS USED WERE ABLE TO MODIFY THE SIGNAL. THE SAMPLE WAS THEN TESTED BY AN ALTERNATE METHOD (ROCHE), WHICH CONFIRMED ACCESS FT3 AND FT4 RESULTS. THE ROOT CAUSE FOR THE DIFFERENCE IN FT3 RESULTS BETWEEN ACCESS FT3 AND THE CUSTOMER'S ALTERNATE METHOD IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT HIGHER THAN EXPECTED FREE TRIIODOTHYRONINE (ACCESS FT3) RESULTS, ABOVE THE NORMAL REFERENCE RANGE, WERE GENERATED BY ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT OVER THE PERIOD BETWEEN (B)(6) 2011. THE RESULTS WERE REPORTED OUT OF THE LABORATORY, AND THE PATIENT RECEIVED ADDITIONAL DRUGS, BISOPROLOL AND MARCUMAR, SINCE THE FIRST ELEVATED FREE T3 RESULT WAS OBTAINED IN (B)(6) 2011. THIS REPORT DOCUMENTS THE EVENT OCCURRED ON (B)(6) 2011. THE RELATED EVENTS ON OTHER DAYS ARE DOCUMENTED IN MDRS LISTED BELOW: 2122870-2012-000193, 2122870-2012-000194, 2122870-2012-000195, 2122870-2012-000197, 2122870-2012-000198.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM, REFURBISHED ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. ACCESS 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other