BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2446755 · Received February 10, 2012

    Report

    Report Number
    2122870-2012-00289
    Event Type
    Malfunction
    Date Received
    February 10, 2012
    Date of Event
    January 20, 2012
    Report Date
    January 20, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY NAME AND THE ADDRESS OF THE INITIAL REPORTER WERE RECORDED IN (B)(6). THE ELECTRONIC 3500A APPLICATION WOULD NOT ALLOW ENTRY OF THE (B)(6) CHARACTERS TO ENTER THE INITIAL REPORTER CONTACT INFORMATION. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED INSTRUMENT ASSAY PERFORMANCE DATA INDICATED THAT THE REFERENCED UE3 QUALITY CONTROL (QC) ISSUES HAD BEEN OCCURRING PRIOR TO THE INTRODUCTION OF THE QUESTIONED REAGENT LOT. FREQUENT CALIBRATIONS AND QC OUTLIERS HAD BEEN GENERATED WITH PREVIOUSLY LOADED REAGENT LOT(S) AS WELL. BECKMAN COULTER INC. REQUESTED ADDITIONAL INSTRUMENT RELATED INFORMATION TO INVESTIGATE THE CAUSE OF THE EVENT, HOWEVER THE ADDITIONAL INFORMATION WAS NOT PROVIDED BY THE CUSTOMER TO DATE. NO ROOT CAUSE CAN BE DETERMINED WITH THE DATA SUPPLIED FOR THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ERRONEOUS UNCONJUGATED ESTRIOL (UE3) RESULTS WERE GENERATED ON AN ACCESS 2 IMMUNOASSAY SYSTEM FOR AN UNSPECIFIED NUMBER OF PATIENTS. THE CUSTOMER INDICATED THAT THEY EXPERIENCED DECREASING MULTIPLE OF MEDIAN VALUES FOR UE3 PATIENT RESULTS AS PART OF THEIR TRISOMY SCREENING. THIS CAUSED MORE FALSE POSITIVE SCREENING RESULTS TO BE GENERATED. UE3 PATIENT RESULT COMPARISONS BETWEEN (B)(6) 2011 TO (B)(6) 2012, DEMONSTRATED A TWENTY PERCENT DECREASE IN UE3 RESULTS BETWEEN THESE TWO TIME PERIODS. THE CUSTOMER ALSO INDICATED THAT SINCE INTRODUCING A NEW UE3 REAGENT LOT, THEY WERE HAVING ERRATIC CALIBRATION RESULTS, CALIBRATION RESULT OUTLIERS AND LOW END IMPRECISION. PATIENT UE3 RESULTS ASSOCIATED WITH THIS EVENT WERE RELEASED FROM THE LABORATORY HOWEVER THERE HAVE BEEN NO REPORTS OF DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. NO ACTUAL PATIENT RESULTS, SPECIFIC PATIENT INFORMATION OR SAMPLE COLLECTION/HANDLING WAS PROVIDED BY THE CUSTOMER.

    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 ACCESS UNCONJUGATED ESTRIOL REAGENT