BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2542292 · Received April 19, 2012

    Report

    Report Number
    2122870-2012-01161
    Event Type
    Injury
    Date Received
    April 19, 2012
    Date of Event
    March 13, 2012
    Report Date
    March 22, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED TO THE SITE FOR THIS EVENT. THE SAMPLE WAS RETURNED TO BECKMAN COULTER INC. FOR PATIENT SAMPLE INTERFERENCE TESTING. SAMPLE TESTING CONFIRMED THE ELEVATED ACCESS TSH AND ACCESS BHCG RESULTS FOR THIS PATIENT WERE CAUSED BY HETEROPHILE INTERFERENCE. HETEROPHILE INVESTIGATIVE TESTING COULD NOT BE PERFORMED FOR ANY OTHER ASSAYS AS THE VOLUME OF SUPPLIED PATIENT SAMPLE WAS TOO LOW TO PERFORM TESTING ON ADDITIONAL ASSAY RESULTS IN QUESTION BY THE CUSTOMER. FOR THE ELEVATED PATIENT TSH AND BHCG RESULTS THE ROOT CAUSE OF THE EVENT IS PATIENT HETEROPHILE INTERFERENCE. FOR THE PATIENT'S PROLACTIN, HUMAN LUTEINIZING HORMONE (HLH), FOLLICLE-STIMULATING HORMONE (FSH), AND FERRITIN RESULTS, THE ROOT CAUSE OF THE EVENT IS UNKNOWN. ASSOCIATED MDRS: 2122870-2012-01030, 2122870-2012-01040, 2122870-2012-01041, 2122870-2012-01042, 2122870-2012-01043, 2122870-2012-01044, 2122870-2012-01161.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ERRONEOUS THYROID STIMULATING HORMONE (TSH), PROLACTIN, HUMAN CHORIONIC GONADOTROPIN (BHCG), HUMAN LUTEINIZING HORMONE (HLH), FOLLICLE-STIMULATING HORMONE (FSH), AND FERRITIN RESULTS WERE GENERATED ON AN ACCESS 2 IMMUNOASSAY SYSTEM FOR A SINGLE PATIENT ACROSS MULTIPLE DAYS. THIS REPORT REPRESENTS THE ERRONEOUSLY ELEVATED THYROID STIMULATING HORMONE (TSH), PROLACTIN, HUMAN CHORIONIC GONADOTROPIN (BHCG), HUMAN LUTEINIZING HORMONE (HLH), FOLLICLE-STIMULATING HORMONE (FSH), AND FERRITIN RESULTS WHICH WERE GENERATED ON AN ACCESS 2 IMMUNOASSAY SYSTEM ON (B)(6) 2012. THE THYROID STIMULATING HORMONE (TSH), PROLACTIN, HUMAN CHORIONIC GONADOTROPIN (BHCG), HUMAN LUTEINIZING HORMONE (HLH), FOLLICLE-STIMULATING HORMONE (FSH), AND FERRITIN RESULTS WERE RELEASED FROM THE LABORATORY. THE PATIENT WAS ADMINISTERED ELTROXIN AND HORMONE REPLACEMENT THERAPY. IT IS UNKNOWN FOR WHICH ASSAY RESULT THE PATIENT WAS ADMINISTERED THE MEDICATIONS. THE MEDICATION HAS SINCE BEEN STOPPED. THE CUSTOMER INDICATED THAT THE INITIAL PATIENT RESULTS WERE CONFIRMED VIA REPEAT TESTING ON ANOTHER BECKMAN COULTER INC. INSTRUMENT, HOWEVER NO INSTRUMENT DETAILS OR PATIENT RESULTS WERE PROVIDED FOR THE SECOND BECKMAN COULTER INC. INSTRUMENT ALLEGEDLY INVOLVED IN THIS EVENT. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED DATA INDICATED THAT UPON REPEAT TESTING USING AN ALTERNATE METHODOLOGY, THE THYROID STIMULATING HORMONE (TSH), PROLACTIN, HUMAN CHORIONIC GONADOTROPIN (BHCG), HUMAN LUTEINIZING HORMONE (HLH), FOLLICLE-STIMULATING HORMONE (FSH), AND FERRITIN RESULTS WERE LOWER, REGARDED AS NORMAL, AND NOT QUESTIONED BY THE CUSTOMER. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED PATIENT DATA INDICATED THAT ADDITIONAL ASSAY RESULTS WERE PROVIDED, HOWEVER THESE RESULTS WERE NOT IN QUESTION IN ASSOCIATION WITH THIS EVENT. THE SAMPLE WAS COLLECTED IN A SERUM SAMPLE TUBE, WAS A FRESH SAMPLE, STORED AT ROOM TEMPERATURE AND WAS TESTED SHORTLY AFTER COLLECTION. THE SAMPLE WAS CENTRIFUGED AT ROOM TEMPERATURE PRIOR TO TESTING. THERE WAS NO SAMPLE QUALITY ISSUES NOTED. ASSAY QUALITY CONTROL (QC) VALUES WERE WITHIN THE CUSTOMER'S ESTABLISHED RANGES DURING THE TIMEFRAME OF THE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention