BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 1840515 · Received September 21, 2010

    Report

    Report Number
    2122870-2010-00549
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 17, 2010
    Report Date
    September 21, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    LGD
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CUSTOMER, TOXO IGG QC HAS BEEN WITHIN THE CUSTOMER'S ESTABLISHED RANGES. THE CUSTOMER SENT SAMPLE TO CUSTOMER PRODUCT LINE SUPPORT (CPLS) EAST FOR ADDITIONAL TESTING. CPLS EAST WAS UNABLE TO REPLICATE THE CUSTOMER'S ERRATIC RESULTS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND VERIFIED INSTRUMENT PERFORMANCE; NOTING THAT IT WAS "OK". A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING ERRATIC TOXO IGG RESULTS ACROSS THE ENTIRE REFERENCE RANGE FOR ONE PATIENT GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. SUBSEQUENT TESTING ON THREE ADDITIONAL ANALYZERS PRODUCED THE SAME ERRATIC RESULTS. ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER LGD BECKMAN COULTER INC. DXI 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1