BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2092039 · Received May 18, 2011

    Report

    Report Number
    2122870-2011-01417
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 16, 2011
    Report Date
    April 21, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED ON (B)(4) 2011 FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE UPPER AND LOWER O-RINGS AND SEALS, AND THE TIMING BELT ON THE PRECISION PUMP. SYSTEM ULTRASONICS, VACUUM, AND THE MIXING BELT SPEED WERE VERIFIED AND FOUND TO BE ACCEPTABLE. A SYSTEM CHECK WAS EXECUTED AND THE RESULTS WERE WITHIN INSTRUMENT SPECIFICATIONS. THE FSE PERFORMED A FIVE REPLICATE, PRECISION TEST USING BOTH LEVELS OF TSH QUALITY CONTROL (QC). THE RESULTS WERE WITHIN THE CUSTOMER'S QC RANGES AND DEMONSTRATED ACCEPTABLE REPRODUCIBILITY. ALTHOUGH THE FSE MADE SEVERAL REPAIRS TO THE INSTRUMENT, A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE CUSTOMER REPORTED ERRATIC HIGH THYROID STIMULATING HORMONE (TSH) QUALITY CONTROL (QC) RESULTS ON THE ACCESS 2 IMMUNOASSAY SYSTEM. SOME RESULTS WERE OUTSIDE OF THE ESTABLISHED QC RANGE. THE QC FAILURES OCCURRED WHEN THE TSH QC WAS RUN IN CONJUNCTION WITH OTHER ASSAY QC PROCESSES. WHEN RUN INDEPENDENTLY, AFTER THE COMPLETION OF OTHER ASSAY QC RUNS, TSH RECOVERED WITHIN ESTABLISHED RANGE. ALTHOUGH THE POTENTIAL FOR ERRONEOUS RESULTS BEING GENERATED DOES EXIST, THERE WERE NO ERRONEOUS RESULTS REPORTED OUT OF THE LAB AND THERE WERE NO REPORTS OF CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS HYPERSENSITIVE HTSH