BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2230314 · Received September 1, 2011

    Report

    Report Number
    2122870-2011-03359
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    July 16, 2011
    Report Date
    August 8, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ORIGINAL SUBMISSION INCORRECTLY INDICATED THAT DEVICE EVALUATION WAS NOT PERFORMED BY THE MANUFACTURER. IN ACTUALITY, INSTRUMENT DIAGNOSTICS IN THE FORM OF INSTRUMENT ASSAY QUALITY CONTROL AND SYSTEM CHECKS WERE EVALUATED BY BECKMAN COULTER INC. TO INVESTIGATE FOR POTENTIAL ROOT CAUSES OF THE EVENT.

    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 DXL800 ACCESS IMMUNOASSAY SYSTEM FOR ELEVEN PATIENTS OVER MULTIPLE DAYS. THIS REPORT IS ONE OF ELEVEN AND REPRESENTS THE ERRONEOUS HBSAG RESULTS FOR PATIENT ONE. 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 HOWEVER REPEAT TESTING OF THE SAMPLE ON THE SAME INSTRUMENT GENERATED A "(B)(6)" HBSAG 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. THE REPEAT RESULT WAS OBTAINED FROM AN ETHYLENEDIAMINETETRAACETIC ACID ANTICOAGULANT TUBE. 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 DXL800 ACCESS IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS (B)(4) AG REAGENT