BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2870409 · Received December 12, 2012

    Report

    Report Number
    2122870-2012-01970
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 14, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    DHA
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS ONE OF TWO REPORTS RELATED TO TWO EVENTS THAT OCCURRED ON TWO DAYS. THIS REPORT IS RELATED TO MDR# 2122870-2012-01966.

    Description of Event or Problem · 1

    ON (B)(6) 2012, AT 3:00 AM, CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT ON (B)(6), 2012, THE ACCESS 2 IMMUNOASSAY ANALYZER (ACCESS 2) GENERATED ERRONEOUS BHCG RESULT AND ERRONEOUS CKMB RESULT FROM TWO DIFFERENT PATIENTS AFTER BEC FIELD SERVICE ENGINEER (FSE) PERFORMED PREVENTIVE MAINTENANCE. CUSTOMER REPORTED THAT THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LAB BECAUSE THEY IMMEDIATELY NOTICED THE RESULTS DID NOT MATCH THE PREVIOUS RESULTS FOR THE TWO PATIENTS. CUSTOMER REPORTED THEY USED ACCESS CK-MB CALIBRATORS, 50-55, LOT 119344 AND ACCESS CK-MB REAGENT KIT (2 X 50 TESTS), LOT 220390, IN CONJUNCTION WITH THE ACCESS 2 ANALYZER. CUSTOMER REPORTED THEY USED ACCESS TOTAL B-HCG CALIBRATORS, LOT 118621, AND ACCESS TOTAL B-HCG, 2 X 50 DETERMINATIONS, LOT 270064, IN CONJUNCTION WITH THE ACCESS 2 ANALYZER. BEC CUSTOMER TECHNICAL SPECIALIST (CTS) TROUBLESHOT THE ISSUE WITH CUSTOMER VIA THE TELEPHONE. CTS ADVISED THE CUSTOMER TO CHECK THE TUBING AT THE PERI-PUMP. CUSTOMER THEN INDICATED THAT ONE OF THE VACUUM TUBINGS WAS KINKED (VACUUM TUBING #2). CTS INSTRUCTED THE CUSTOMER TO DETACH THE TUBING FROM THE MANIFOLD AND TRIM THE TUBING TO A BETTER LENGTH TO TRY TO ALLEVIATE THE KINK. THE CUSTOMER THEN RAN QUALITY CONTROL (QC) WITH FAILING RESULTS. CUSTOMER REPORTED THEY DID SOME MORE CHECKING OF THE FITTINGS INSIDE THE ACCESS 2 ANALYZER AFTER THE QC FAILED TO PASS WITHIN ESTABLISHED RANGES. CUSTOMER REPORTED THEY TIGHTENED SOME FITTINGS. CUSTOMER REPORTED THEY THEN RAN QC TWICE FOR ALL THE ASSAYS AND THE RESULTS FOR BOTH QC RUNS WERE WITHIN THE CUSTOMER'S ESTABLISHED LIMITS. CUSTOMER DECLINED ON-SITE SERVICE FROM BEC. CUSTOMER INDICATED THEY WOULD MONITOR THE INSTRUMENT. ON (B)(6) 2012, AT 7:00 AM, THE CUSTOMER REPORTED THAT THE ACCESS 2 ANALYZER GENERATED ERRONEOUS PROSTATE SPECIFIC ANTIGEN (PSA), TOTAL T4, AND T UPTAKE FOR THREE PATIENTS. (SEE MDR# 2122870-2012-01966). ON (B)(4) 2012, BEC FIELD SERVICE ENGINEER (FSE) REPLACED THE PRECISION PUMP SEALS TO ADDRESS THE IMPRECISION ISSUES REPORTED BY THE CUSTOMER. THE FSE THEN OBSERVED CLOUDINESS WITHIN THE INSTRUMENT WASH PUMP AND REPLACED THE ENTIRE WASH PUMP. THE FSE PERFORMED SYSTEM CHECK AND PRECISION RUNS ON THE AFFECTED ASSAYS AND OBTAINED ACCEPTABLE RESULTS. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1