BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY ANALYZER

    MDR report key: 1914702 · Received December 3, 2010

    Report

    Report Number
    2122870-2010-00856
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 4, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL TBHCG SAMPLES ARE RUN IN DUPLICATE. QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES DURING THE EVENT. SERVICE WAS DISPATCHED ON (B)(4) 2010. THE FIELD SERVICE ENGINEER (FSE) PERFORMED A PRECISION TEST, AND THE RESULTS MET PRECISION 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 TOTAL BETA HCG RESULT GENERATED BY UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER FOR ONE PATIENT. THE RESULT WAS NOT REPORTED OUT OF THE LABORATORY. SUBSEQUENT TESTING PRODUCED A HIGHER RESULT WHICH BETTER MATCHED THE PATIENT'S CLINICAL PICTURE. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO 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