BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 3812362 · Received May 15, 2014

    Report

    Report Number
    2122870-2014-00372
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 18, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) REPLACED THE PRECISION PUMP BELT AND SEALS AND RESOLVED THE ISSUE. THE FSE COMPLETED SYSTEM CHECK, QUALITY CONTROL (QC), AND ASSAY PRECISION TEST; ALL TEST RESULTS PASSED WITHIN SPECIFICATIONS. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. IN CONCLUSION, THE LIKELY CAUSE OF THE EVENT IS ATTRIBUTED TO THE PRECISION PUMP. BECKMAN COULTER CONTINUES TO TRACK AND TREND ANY INCIDENT RELATED TO THIS ISSUE. ALL RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS INCIDENT: 2122870-2014-00370, 2122870-2014-00371, 2122870-2014-00372, 2122870-2014-00373, 2122870-2014-00374, 2122870-2014-00379, 2122870-2014-00380, 2122870-2014-00381.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUS TOTAL BETA HUMAN CHORIONIC GONADOTROPHIN (TBHCG), ALPHA-FETOPROTEIN (AFP), AND UNCONJUGATED ESTRIOL RESULTS, FOR MULTIPLE PATIENTS, INVOLVING THE ACCESS® 2 IMMUNOASSAY SYSTEM. THIS REPORT IS THREE OF EIGHT REFERENCING THE TWO PATIENTS WITH THE ERRONEOUS TBHCG RESULTS. THE ERRONEOUS RESULTS WERE NOT RELEASED OUT OF THE LABORATORY. SUBSEQUENT TESTING OF ONE OF THE PATIENTS' SAMPLES, ON THE SAME INSTRUMENT, PRODUCED VARIED RESULTS. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS EVENT. PER LABORATORY PROTOCOL, RANDOMLY RETESTED SAMPLES, VARIED BY GREATER THAN (>) 10%, ARE REANALYZED. THE CUSTOMER INDICATED THE PATIENTS' SERUM SAMPLES WERE NORMAL IN APPEARANCE; NO SAMPLE INTEGRITY ISSUES WERE NOTED. THE CUSTOMER INDICATED QUALITY CONTROL (QC) WAS WITHIN THE LABORATORY'S ACCEPTABLE RANGE AT THE TIME OF THE EVENT. THERE WERE NO SYSTEM ERRORS IN THE EVENT LOG. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291653 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1