BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS INHIBIN A

    MDR report key: 7148746 · Received December 27, 2017

    Report

    Report Number
    2122870-2017-00059
    Event Type
    Malfunction
    Date Received
    December 27, 2017
    Date of Event
    December 4, 2017
    Report Date
    December 5, 2017
    Manufacturer
    BECKMAN COULTER
    Product Code
    NDR
    UDI-DI
    15099590203047
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCESS INHIBIN A REAGENT WAS NOT RETURNED FOR EVALUATION. A BECKMAN COULTER FIELD SERVICE ENGINEER WAS NOT DISPATCHED TO THE CUSTOMER'S SITE. THERE IS NO EVIDENCE TO REASONABLY SUGGEST A SYSTEM MALFUNCTION; SYSTEM PARAMETERS (CALIBRATIONS AND QC) MET ASSAY AND INSTRUMENT SPECIFICATIONS. THERE WERE NO INDICATIONS OF INSTRUMENT ERROR MESSAGES AT THE TIME OF THE EVENT. THE CUSTOMER ATTRIBUTED THE ERRONEOUS RESULTS TO FIBRIN IN ONE OF THE PATIENT SAMPLES. PER CLINICAL AND LABORATORY STANDARDS INSTITUTE (CLSI) GUIDELINE-GP44-A4: PROCEDURES FOR THE HANDLING AND PROCESSING OF BLOOD SPECIMENS FOR COMMON LABORATORY TESTS. FOURTH EDITION, "RESIDUAL FIBRIN, A POSSIBLE INTERFERENT IN THE CLINICAL LABORATORY, MAY OCCUR SECONDARY TO IMPROPER SPECIMEN HANDLING DURING OR AFTER COLLECTION. FIBRIN MAY DIRECTLY AFFECT SOME ASSAYS. FIBRIN INTERFERENCE IS USUALLY NOT REPRODUCIBLE." THE CUSTOMER DECLINED TO PERFORM HARDWARE TROUBLESHOOTING. IN CONCLUSION ALTHOUGH SAMPLE INTEGRITY MAY HAVE CONTRIBUTED TO THIS EVENT, AN ASSIGNABLE CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING NON-REPRODUCIBLE, LOW DIMERIC INHIBIN A (ACCESS INHIBIN A) RESULTS FOR FOUR PATIENT SAMPLES ON THE LABORATORY'S UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)). THE INITIAL RESULTS WERE LOWER THAN THE CUSTOMER EXPECTED. THE CUSTOMER WAS ANALYZING THE SAMPLES AS PART OF A MATERNAL SCREEN WHICH INCLUDED ALPHA-FETOPROTEIN (ACCESS AFP) UNCONJUGATED ESTRIOL (ACCESS UNCONJUGATED ESTRIOL) BETA HUMAN CHORIONIC GONADOTROPIN (ACCESS TOTAL BHCG (5TH IS)) AND ACCESS INHIBIN A. THE INITIAL RESULTS FROM THE FOUR ASSAYS RECOVERED BELOW THE CUSTOMER'S EXPECTATIONS FOR THE FOUR PATIENT SAMPLES. AN ADDITIONAL SEVEN PATIENT SAMPLES ANALYZED AT THE SAME TIME RECOVERED WITH INITIAL RESULTS BELOW THE CUSTOMER'S EXPECTATIONS. THE INITIAL RESULTS WERE NOT RELEASED FROM THE LABORATORY. THERE WAS NO CHANGE TO PATIENT CARE OR TREATMENT WHICH OCCURRED IN ASSOCIATION WITH NON-REPRODUCIBLE ACCESS PATIENT RESULTS. THE PATIENTS' SAMPLES WERE REANALYZED ON THE SAME UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM AND RECOVERED WITH HIGHER RESULTS, WITHIN THE CUSTOMER'S EXPECTED VALUES. CALIBRATIONS AND QUALITY CONTROL (QC) WERE PERFORMING WITHIN ASSAY AND INSTRUMENT SPECIFICATIONS AT THE TIME OF THE EVENT. THERE WERE NO HARDWARE ERRORS REPORTED IN CONJUNCTION WITH THIS EVENT. THE SAMPLES WERE COLLECTED IN SERUM SEPARATOR TUBES. INFORMATION ON CENTRIFUGATION TIME, SPEED AND TEMPERATURE WAS NOT PROVIDED. THE CUSTOMER IDENTIFIED FIBRIN IN ONE OF THE PATIENT'S SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929397 ACCESS INHIBIN A ENZYME IMMUNOASSAY, INHIBIN-A NDR BECKMAN COULTER NA 723809 15099590203047

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR