BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2233559 · Received September 2, 2011

    Report

    Report Number
    2122870-2011-03403
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    July 16, 2011
    Report Date
    August 8, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED TO THE SITE FOR THIS EVENT. NO DEFINITIVE ROOT CAUSE WAS DETERMINED FOR THIS EVENT TO DATE. MDRS ASSOCIATED WITH THIS EVENT: 2122870-2011-03359, 2122870-2011-03360, 2122870-2011-03361, 2122870-2011-03362, 2122870-2011-03363, 2122870-2011-03364, 2122870-2011-03365, 2122870-2011-03402, 2122870-2011-03403, 2122870-2011-03404, 2122870-2011-03405.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ERRONEOUS HEPATITIS B SURFACE ANTIGEN (HBSAG) RESULTS WERE GENERATED ON A UNICEL DXL 800 ACCESS IMMUNOASSAY SYSTEM USED IN CONJUNCTION WITH ACCESS HBSAG REAGENT (LOT 192336) FOR ELEVEN PATIENTS OVER MULTIPLE DAYS. THIS REPORT IS ONE OF ELEVEN AND REPRESENTS THE ERRONEOUS HBSAG RESULTS FOR PATIENT NINE. THE EXACT DATE ON WHICH THE ERRONEOUS PATIENT RESULT WAS GENERATED IS UNKNOWN, AND WILL BE INFERRED AS (B)(6) 2011. THE INITIAL HBSAG TESTING OF THE PATIENT SAMPLE RESULTED IN A "(B)(6)" HBSAG RESULT. REPEAT TESTING OF THE SAMPLE ON THE SAME INSTRUMENT IN AN ETHYLENEDIAMINETETRAACETIC ACID ANTICOAGULANT (EDTA) TUBE ALSO GENERATED A "(B)(6)" HBSAG RESULT. REPEAT TESTING OF THE SAMPLE VIA AN ALTERNATE METHODOLOGY GENERATED A "(B)(6)" RESULT. THE INITIAL HBSAG WAS REPORTED OUT OF THE LABORATORY. WHILE THERE IS NO REPORT OF ADVERSE EVENT OR SERIOUS INJURY RELATED TO THIS EVENT, IT IS UNKNOWN WHETHER THERE WAS A CHANGE TO PATIENT MANAGEMENT. NO ADDITIONAL SAMPLE COLLECTION/HANDLING INFORMATION WAS PROVIDED BY THE CUSTOMER. THE INSTRUMENT'S HBSAG QUALITY CONTROL RESULTS WERE WITHIN CUSTOMER ESTABLISHED SPECIFICATIONS DURING THE TIMEFRAME OF THIS EVENT. AN INSTRUMENT SYSTEM CHECK PERFORMED PRIOR TO THE EVENT TIMEFRAME GENERATED ACCEPTABLE RESULTS. PATIENT SPECIFIC INFORMATION WAS NOT PROVIDED BY THE CUSTOMER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1