BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1895681 · Received November 10, 2010

    Report

    Report Number
    2122870-2010-00721
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 4, 2010
    Report Date
    November 10, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE HEPARINIZED PLASMA WITH GEL BARRIERS THAT WERE CENTRIFUGED FOR 3 MINUTES AT 3700RPM. THE COLLECTION TUBE WAS FILLED TO THE RECOMMENDED VOLUME. QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES DURING THIS EVENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2010 AND INITIALLY PERFORMED MINOR PREVENTATIVE MAINTENANCE (PM) ON THE INSTRUMENT. THE FSE ALSO REPLACED THE WASH VALVE ROTOR DUE TO SOME RUST AND AFFIXED THE LABEL ON THE REAGENT STORAGE DOOR. A HIGH SENSITIVITY (HS) SYSTEM CHECK WAS PERFORMED ON THE INSTRUMENT AND MET SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING AN ACCUTNI (TROPONIN) RESULT IN THE RISK STRATIFICATION RANGE FOR ONE'S PATIENT SAMPLE THAT WAS GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM. REPEAT TESTING AND A SUBSEQUENT SAMPLE RESULTED IN THE NORMAL REFERENCE RANGE. THE ERRONEOUS RESULT WAS REPORTED OUT OF THE LABORATORY; HOWEVER, THE REPORT WAS AMENDED BY THE SUBSEQUENT RESULT. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION DUE TO THE ERRONEOUSLY HIGH RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER INC. ACCESS 2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization