BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2297087 · Received October 14, 2011

    Report

    Report Number
    2122870-2011-04561
    Event Type
    Malfunction
    Date Received
    October 14, 2011
    Date of Event
    September 14, 2011
    Report Date
    September 15, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DETAILS REGARDING SAMPLE COLLECTION OR SAMPLE PROCESSING HAS BEEN PROVIDED. QC IS RUN EVERY 24 HOURS. QC WAS IN RANGE ON (B)(6) 2011. QC WAS RUN AFTER PIPETTOR #3 WAS DISABLED. QC WAS SUCCESSFUL ON ALL OF THE OTHER PIPETTORS. SERVICE WAS DISPATCHED FOR THIS EVENT: A FIELD SERVICE ENGINEER (FSE) DISCOVERED THAT PIPETTOR #3 TUBING WAS CRACKED AND REPLACED THE TUBING. THE FSE ADJUSTED ULTRASONICS. AFTER SERVICE COMPLETION, SYSTEM CHECK TEST PASSED AND QC RECOVERED WITHIN SPECIFICATIONS. ROOT CAUSE HAS BEEN DETERMINED TO BE HARDWARE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) AND REPORTED THAT MULTIPLE ERRONEOUS TOTAL IMMUNOGLOBULIN E (IGE) AND RED BLOOD CELL (RBC) FOLATE RESULTS WERE GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. SERVICE WAS DISPATCHED AND WHILE ON-SITE, THE ISSUE WAS ISOLATED TO PIPETTOR #3. ALL SAMPLES TESTED ON PIPETTOR #3 WERE RE-TESTED. TEN (10) SAMPLE REPORTS WERE AMENDED. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER INC. DXI 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1