BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY ANALYZER

    MDR report key: 2001862 · Received February 25, 2011

    Report

    Report Number
    2122870-2011-00502
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    January 27, 2011
    Report Date
    January 28, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED IN A LITHIUM HEPARIN PLASMA TUBE WITH A GEL BARRIER, AND WAS CENTRIFUGED FOR 6 MINUTES AT 3000 RPM. THE COLLECTION TUBE HAD THE PROPER FILL VOLUME. QC IS PERFORMED EVERY 12 HOURS AND WAS WITHIN THE ESTABLISHED RANGES PRIOR TO AND AFTER THE EVENT. THE CUSTOMER REPEATED 10 RANDOMLY SELECTED PREVIOUS SAMPLES, AND THE RESULTS WERE REPRODUCIBLE. BCI FIELD SERVICE ENGINEER (FSE) VISITED THE SITE ON (B)(4) 2011 AND REPLACED PERI PUMP TUBING AND ASPIRATE PROBES. A SYSTEM CHECK AND A HIGH SENSITIVITY SYSTEM CHECK WERE PERFORMED AND BOTH RESULTS MET THE SPECIFICATIONS. NO CLEAR ROOT CAUSE FOR THE EVENT HAS BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A LOWER THAN EXPECTED POSITIVE TOTAL BETA HCG (TBHCG) RESULT GENERATED BY UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER FOR ONE PATIENT'S SAMPLE. THE RESULT WAS REPORTED OUT OF THE LABORATORY. SUBSEQUENT TESTING ON THE SAME AND ON AN ALTERNATE INSTRUMENT PRODUCED RESULTS IN A HIGHER CLINICAL CATEGORY. THE CUSTOMER DOES NOT KNOW IF THERE WAS 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 ANALYZER DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. DXI 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1