BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXL 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 1884373 · Received October 27, 2010

    Report

    Report Number
    2122870-2010-00669
    Event Type
    Malfunction
    Date Received
    October 27, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 27, 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
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LEVEL 1 AND 3 QC WAS OUT OF RANGE HIGH ON THE DAY OF THE EVENT. LEVEL 2 QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES. THE CUSTOMER INDICATED THAT CERTAIN REAGENT PACKS WOULD PRODUCE ELEVATED RESULTS THROUGH THE ENTIRE PACK WHILE REPEAT ANALYSIS ON A DIFFERENT REAGENT PACK FROM THE SAME LOT WOULD PRODUCE RESULTS THAT BETTER MATCHED THE CUSTOMER'S EXPECTATION OF THE ASSAY. A FIELD SERVICE ENGINEER (FSE) WAS ON-SITE (B)(6) 2010. ALL VERIFICATION TESTING PASSED WITHIN INSTRUMENT SPECIFICATIONS. VERIFICATION TESTING PERFORMED BY A HARDWARE SPECIALIST ON 10/11/2010 ALSO PASSED WITHIN INSTRUMENT SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING HIGHER THAN EXPECTED THYROGLOBULIN AUTO ANTIBODIES (TGAB) RESULTS GENERATED BY THE UNICEL DXL 800 ACCESS IMMUNOASSAY SYSTEM FOR SEVERAL PATIENTS. NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1