BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2924247 · Received January 22, 2013

    Report

    Report Number
    2122870-2013-00043
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 27, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    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

    NO SAMPLE INFORMATION WAS PROVIDED BY THE CUSTOMER. THERE WAS NO SYSTEM INFORMATION PROVIDED FOR REVIEW. THE CUSTOMER HAD INITIALLY CALLED FOR SERVICE IN RESPONSE TO FAILING INHIBIN A CALIBRATION ATTEMPTS AND IMPRECISE INHIBIN A QC AND PATIENT PRECISION RUN RECOVERY. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO VERIFY HARDWARE PERFORMANCE IN RESPONSE TO THIS COMPLAINT. THE FSE PERFORMED SEVERAL REPAIRS TO THE ANALYZER WHILE ON-SITE. THE FSE REPLACED MIXER BELT, MIXER ASSEMBLY, MIXER ROLLERS, AND PIPETTOR PROBE. THE FSE CLEANED AN INCUBATOR BELT AND CAROUSEL, THE WASH AND PRECISION VALVES. THE FSE VERIFIED THE TRANSDUCER VOLTAGE, REACTION VESSELS (RVS), INCUBATOR BELT, AND INCUBATOR BEARINGS. THE FSE VERIFIED THE PIPETTOR DISPENSE CHECK AND CONFIRMED THERE WERE NO BUBBLES IN THE WASH PUMP. THE CUSTOMER CONFIRMED THERE HAVE BEEN NO FURTHER ISSUES WITH THE ANALYZER PERFORMANCE FOLLOWING THE REPAIRS COMPLETED BY THE FSE. ALTHOUGH A SPECIFIC MALFUNCTION WAS NOT IDENTIFIED BY THE FSE, A HARDWARE/SYSTEM MALFUNCTION IS THE LIKELY CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    A CUSTOMER HAD INITIALLY CALLED BECKMAN COULTER INC., (BEC), FOR SERVICE IN RESPONSE TO INHIBIN A CALIBRATION AND QC ISSUES AND PATIENT PRECISION RUN RECOVERY. HOWEVER, DURING CONVERSATION WITH THE FIELD SERVICE ENGINEER (FSE) THE CUSTOMER INDICATED THAT THEY OBTAINED AN ERRONEOUSLY ELEVATED INHIBIN A RESULT FOR ONE FEMALE PATIENT USING THE LABORATORY'S ACCESS 2 IMMUNOASSAY SYSTEM. AN INITIAL RESULT OF 42.9 IU/ML WAS OBTAINED AND THE PATIENT SAMPLE WAS RE-TESTED ON THE NEXT DAY DUE TO THE LABORATORY'S PROTOCOL TO REPEAT PATIENT SAMPLES IN WHICH ELEVATED RESULTS ARE OBTAINED. THE REPEAT RESULT WAS 9.4 IU/ML. THE ERRONEOUSLY ELEVATED INHIBIN A RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY; THEREFORE, THERE WAS NO CHANGE TO, OR IMPACT ON, PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30371 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER INC. ACCESS® 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1