BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1912084 · Received December 1, 2010

    Report

    Report Number
    2122870-2010-00854
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 8, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BCI FIELD SERVICE ENGINEER (FSE) WAS ON SITE ON (B)(6) 2010. THE FSE REVIEWED TRANSDUCER VOLTAGE, AND ADJUSTED TRANSDUCER TEMPERATURE TO THE SPECIFICATION AND ALLOWED IT TO STABILIZE. THE FSE ADJUSTED NEW TRANSDUCER AND HIGH VOLTAGE. THE FSE COMPLETED ALL NECESSARY ALIGNMENT OFFSET ADJUSTMENTS. THE FSE PRIMED THE INSTRUMENT AND PERFORMED A SYSTEM CHECK, FOLLOWED BY 5 REPLICATE PRECISION FOR CARDIAC QC ON A NEW 'UNMIXED' ACCUTNI REAGENT PACK. ALL RESULTS WERE WITHIN THE SPECIFICATIONS. HARDWARE IS THE SUSPECTED ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO FAILING TROPONIN (ACCUTNI) QC RESULTS GENERATED BY UNICEL DXC 600I ACCESS 2 IMMUNOASSAY SYSTEM. THE CUSTOMER HAD LOADED A NEW ACCUTNI REAGENT PACK AND RAN QC, WHICH PRODUCED RESULTS BELOW THE ESTABLISHED RANGE. THERE WAS NO REPORT FROM THE CUSTOMER THAT ANY PATIENT RESULTS WERE GENERATED IN ASSOCIATION WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I ACCESS® 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1