BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS TOTAL BHCG

    MDR report key: 4825210 · Received June 8, 2015

    Report

    Report Number
    2122870-2015-00341
    Event Type
    Malfunction
    Date Received
    June 8, 2015
    Date of Event
    May 11, 2015
    Report Date
    May 12, 2015
    Manufacturer
    BECKMAN COULTER
    Product Code
    DHA
    PMA / PMN Number
    K980173
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCESS TOTAL BHCG REAGENT WAS NOT RETURNED FOR EVALUATION. ALL ASSAY AND SYSTEM VERIFICATIONS MET SPECIFICATIONS. THE CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING NON-REPRODUCIBLE HUMAN CHORIONIC GONADOTROPIC (ACCESS TOTAL BHCG) RESULTS ON THE UNICEL DXI 800 IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)) FOR ONE (1) PATIENT. THE INITIAL ACCESS TOTAL BHCG RESULT WAS ABOVE THE EXPECTED VALUE. THE SAME PATIENT'S SAMPLE WAS REPEATED TWO (2) ADDITIONAL TIMES ON THE SAME UNICEL DXI 800 IMMUNOASSAY SYSTEM AND RECOVERED WITH LOWER RESULTS, ONE RESULT ABOVE THE EXPECTED VALUE AND ONE RESULT WITHIN THE EXPECTED VALUE. SYSTEM PARAMETERS INCLUDING QUALITY CONTROL (QC), CALIBRATION, SYSTEM CHECK AND CARRYOVER WERE WITHIN ASSAY/INSTRUMENT SPECIFICATIONS. THE PATIENT'S SAMPLE WAS COLLECTED IN A 13 X 100 HEPARIN ANTICOAGULANT TUBE. THE SAMPLE WAS 30 MINUTES OLD, STORED REFRIGERATED AND CENTRIFUGED AT 3000 REVOLUTIONS PER MINUTE (RPM) 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
    368158 ACCESS TOTAL BHCG SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA BECKMAN COULTER NA 429538

    Patients

    Seq Age Sex Outcome Treatment
    1