BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2216936 · Received August 19, 2011

    Report

    Report Number
    2122870-2011-02991
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    June 10, 2011
    Report Date
    July 19, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    LGD
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND CENTRIFUGATION INFORMATION HAS NOT BEEN SUPPLIED TO DATE. PER THE CUSTOMER COMPLAINT RECORD, TOXO IGM QC HAS BEEN WITHIN THE CUSTOMER'S ESTABLISHED RANGES. SPECIFIC QC DATA HAS NOT BEEN SUPPLIED TO DATE. ADDITIONAL SYSTEM INFORMATION HAS NOT BEEN SUPPLIED TO DATE. THE CUSTOMER IS SENDING THE SAMPLE TO AN OUTSIDE FACILITY FOR FURTHER EVALUATION. ADDITIONAL RESULTS AND INFORMATION HAS NOT YET BEEN PROVIDED TO DATE. NO INDICATION HAS SHOWN THAT SERVICE WAS DISPATCHED FOR THIS EVENT. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT. THIS REPORT IS RELATED TO MDRS 2122870-2011-02992 AND 2122870-2011-02993 THAT ARE REPORTING ON A DIFFERENT DATES, FOR THE SAME PATIENT, AND FOR SIMILAR EVENTS THAT OCCURRED AT THIS CUSTOMER SITE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) IN REGARDS TO OBTAINING A FALSE NON-REACTIVE TOXO IMMUNOGLOBULIN M (IGM) RESULT FOR ONE (1) PATIENT, GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM AND USED IN CONJUNCTION WITH ACCESS TOXO IGM REAGENT (LOT #091278) AND ACCESS TOXO IGM CALIBRATORS (LOT #091253). SUBSEQUENT TESTING PRODUCED A REACTIVE RESULT FOR THE SAME SAMPLE. THE DISCORDANT RESULT WAS REPORTED OUT OF THE LABORATORY. 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 SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER LGD BECKMAN COULTER INC. DXI 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1