BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS UNCONJUGATED ESTRIOL REAGENT

    MDR report key: 5180711 · Received October 27, 2015

    Report

    Report Number
    2122870-2015-00699
    Event Type
    Malfunction
    Date Received
    October 27, 2015
    Date of Event
    October 1, 2015
    Report Date
    October 2, 2015
    Manufacturer
    BECKMAN COULTER
    Product Code
    CGI
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH OR WEIGHT. THE ACCESS UNCONJUGATED ESTRIOL 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 ONE (1) NON-REPRODUCIBLY ELEVATED UNCONJUGATED ESTRIOL (ACCESS UNCONJUGATED ESTRIOL) RESULT WHICH WAS OBTAINED ON THE LABORATORY'S ACCESS 2 IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)) FOR ONE (1) PATIENT. THE ACCESS UNCONJUGATED ESTRIOL WAS PERFORMED AS PART OF A MATERNAL SERUM TRIPLE SCREENING TEST. THE SCREENING WAS PERFORMED ON (B)(6) 2015 AND AN INITIAL ACCESS UNCONJUGATED ESTRIOL RESULT OF 0.5 NMOL/L WAS OBTAINED. THE SAME SAMPLE WAS REPEATED AS PART OF THE LABORATORY'S REPEAT PROTOCOL FOR ACCESS UNCONJUGATED ESTRIOL RESULTS OF LESS THAN 1.0 NMOL/L AND RESULTS OF 5.34 NMOL/L AND 0.53 NMOL/L WERE OBTAINED. PER THE CUSTOMER, THE LOWER ACCESS UNCONJUGATED ESTRIOL RESULTS WERE CORRECT AS THE RESULTS MET THE CLINICAL PRESENTATION OF THE PATIENT. THE RESULTS WERE NOT RELEASED FROM THE LABORATORY. THERE WERE NO REPORTS OF PATIENT INJURY OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. SYSTEM PARAMETERS INCLUDING CALIBRATION, QUALITY CONTROL (QC) AND SYSTEM CHECKS WERE WITHIN ASSAY/INSTRUMENT SPECIFICATIONS. THERE WERE NO ERRORS POSTED IN THE EVENT LOG. A PRECISION RUN WAS PERFORMED USING LOW CONTROL QC. THE PRECISION RUN MET ASSAY AND SYSTEM SPECIFICATIONS. ALPHA-FETOPROTEIN (ACCESS AFP) AND HUMAN CHORIONIC GONADOTROPIN (ACCESS TOTAL BHCG (5TH IS)) TESTS WERE ALSO PERFORMED AS PART OF THE MATERNAL SERUM SCREENING. RESULTS FOR BOTH ASSAYS WERE REPRODUCIBLE AND NOT QUESTIONED. THE SAMPLE WAS COLLECTED IN A BECTON DICKINSON (BD) SERUM SEPARATOR TUBE (SST) AND WAS SPUN PRIOR TO ARRIVING AT THE LAB FOR TESTING. SAMPLE PROCESSING INFORMATION WAS NOT PROVIDED. THE ORIGINAL SERUM TUBE WAS PULLED AND INSPECTED. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711458 ACCESS UNCONJUGATED ESTRIOL REAGENT RADIOIMMUNOASSAY, ESTRIOL CGI BECKMAN COULTER NA 437160

    Patients

    Seq Age Sex Outcome Treatment
    1