BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS HFSH REAGENT

    MDR report key: 6043693 · Received October 20, 2016

    Report

    Report Number
    9680746-2016-00004
    Event Type
    Injury
    Date Received
    October 20, 2016
    Date of Event
    September 22, 2016
    Report Date
    September 26, 2016
    Manufacturer
    BECKMAN COULTER IRELAND
    Product Code
    CGJ
    UDI-DI
    15099590209353
    PMA / PMN Number
    K940005
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT SUPPLY PATIENT'S DATE OF BIRTH AND WEIGHT. THERE IS NO EVIDENCE THAT THE ACCESS HFSH REAGENT WAS RETURNED FOR EVALUATION. A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS NOT DISPATCHED TO THE CUSTOMER'S SITE. THE CUSTOMER WAS ADVISED TO SEND THE PATIENT'S SAMPLE TO THE BECKMAN COULTER COMPLAINT HANDLING UNIT (CHU) FOR EVALUATION. THE MARSEILLES CHU RECEIVED ONE (1) SAMPLE FOR INVESTIGATION. THE PATIENT'S SAMPLE WAS ANALYZED UTILIZING THE ACCESS HFSH ASSAY ON THE ACCESS 2 IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)). THE MARSEILLES CHU OBTAINED ONE (1) ELEVATED RESULT AND CONFIRMED CUSTOMER'S RESULTS. FURTHER TESTING OF THIS SAMPLE, WITH BLOCKER PROTEINS, DECREASED THE SAMPLE'S SIGNAL CAUSING A DECREASE IN THE ACCESS HFSH RESULT BY 66%, CONFIRMING THE PRESENCE OF A PATIENT SOURCE INTERFERENT RELATED TO HETEROPHILE ANTIBODIES. IN CONCLUSION, THE CAUSE OF THE ELEVATED ACCESS HFSH RESULTS IS DUE TO A PATIENT SOURCE INTERFERENT RELATED TO HETEROPHILE ANTIBODIES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING REPEATABLE ELEVATED FOLLICLE STIMULATING HORMONE (ACCESS HFSH) RESULTS FOR ONE (1) PATIENT INVOLVING THE LABORATORY'S UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)) THAT WERE DISCORDANT TO THE PATIENT'S CLINICAL FILE. THE INITIAL ACCESS HFSH RESULT RECOVERED ABOVE THE ASSAY'S NORMAL REFERENCE RANGE. THE CUSTOMER REANALYZED THE PATIENT'S SAMPLE SEVERAL ADDITIONAL TIMES (NO PRECISION PROVIDED) ON THE SAME LABORATORY'S UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)) AND OBTAINED ELEVATED RESULTS RECOVERING ABOVE THE ASSAY'S NORMAL REFERENCE RANGE AGAIN. DUE TO THESE ELEVATED ACCESS HFSH RESULTS, THE PATIENT UNDERWENT A STIMULATION TEST. THERE WAS NO REPORT OF ADDITIONAL CHANGE TO TREATMENT IN CONJUNCTION WITH THIS EVENT. CALIBRATIONS, QUALITY CONTROLS (QC) AND SYSTEM CHECKS WERE PERFORMING WITHIN ASSAY AND INSTRUMENT SPECIFICATIONS. NO HARDWARE ERRORS, FLAGS OR OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. THE PATIENT'S SAMPLE WAS COLLECTED IN A SERUM TUBE AND WAS CENTRIFUGED AT 3,000 RPM (ROTATIONS PER MINUTE) FOR TEN (10) MINUTES AT ROOM TEMPERATURE. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695924 ACCESS HFSH REAGENT RADIOIMMUNOASSAY, FOLLICLE-STIMULATING HORMONE CGJ BECKMAN COULTER IRELAND NA 570257 15099590209353

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other