BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 3000808 · Received March 12, 2013

    Report

    Report Number
    2122870-2013-00285
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 12, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) PERFORMED A DILUTED HUMAN CHORIONIC GONADOTROPHIN (DIL-HCG) PRECISION STUDY WITH A PERCENT COEFFICIENT OF VARIATION OF (%CV) OF 11.4%. THE FSE NOTED THE CUSTOMER REPLACED THE TRANSDUCER AND ULTRASONICS BOARD BUT DID NOT IMPROVE PERFORMANCE. THE FSE THEN REPLACED THE PRECISION PUMP AND PERFORMED A SECOND DIL-HCG PRECISION STUDY WITH A %CV OF 1.9%. THE FSE PROACTIVELY REPLACED THE INSTRUMENT WASH TOWER AND THE EXHAUST FAN AFTER OBSERVING SOME VISIBLE AND AUDIBLE ISSUES. SYSTEM CHECKS AND HIGH SENSITIVITY SYSTEM CHECKS WERE PASSED WITHIN SPECIFICATIONS PRIOR TO SERVICE. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED SPECIFICATIONS. WASH TOWER. ALL RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS INCIDENT: 2122870-2013-00284, 2122870-2013-00285, 2122870-2013-00286.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRATIC AND IMPRECISE DILUTED BETA HUMAN CHORIONIC GONADOTROPHIN (BHCG) RESULTS FOR THREE PATIENTS, ON SEPARATE DAYS, INVOLVING THE ACCESS 2 IMMUNOASSAY SYSTEM. SUBSEQUENT ANALYSES OF THE PATIENT'S SAMPLES, ON AN ALTERNATE ACCESS 2 SYSTEM, RECOVERED REPRODUCIBLE RESULTS THAT CORRELATED WITH THE PATIENT'S CLINICAL STATUS. THE ERRATIC RESULTS WERE NOT RELEASED OUT OF THE LABORATORY. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. PATIENT SAMPLES WERE COLLECTED BY THE EMERGENCY DEPARTMENT (ED) STAFF IN 13X100 ML SERUM SEPARATION TUBES (SST) AND CENTRIFUGED AT 5,000 RPM (ROTATIONS PER MINUTE) FOR TEN MINUTES. THE CUSTOMER ALLOWS SAMPLES TO CLOT BETWEEN FIVE TO TEN MINUTES PRIOR TO CENTRIFUGATION. QUALITY CONTROL (QC) AND SYSTEM CHECK WERE WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THIS IS REPORT TWO OF THREE REFERENCING THE EVENT DATE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103213 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR