BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXL 600 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2242281 · Received September 10, 2011

    Report

    Report Number
    2122870-2011-03497
    Event Type
    Malfunction
    Date Received
    September 10, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 16, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED TO THE SITE TO ADDRESS THE ISSUE. NO INSTRUMENT CALIBRATION, QUALITY CONTROL OR SYSTEMS INFORMATION WAS PROVIDED BY THE CUSTOMER FOR EVALUATION. THE PATIENT SAMPLE HAS BEEN DISPATCHED TO BECKMAN COULTER INC. CUSTOMER PRODUCT LINE SUPPORT FOR EVALUATION. BECKMAN COULTER INC. INVESTIGATION IS CURRENTLY IN PROGRESS A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 AN ELEVATED VITAMIN B12 RESULT WAS GENERATED ON AN UNICEL DXL 600 ACCESS IMMUNOASSAY SYSTEM FOR ONE PATIENT. THE INITIAL VITAMIN B12 RESULT, WHICH WAS ABOVE THE REFERENCE RANGE, WAS NOT RELEASED FROM THE LABORATORY, AND HENCE THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. REPEAT VITAMIN B12 TESTING ON THE SAME INSTRUMENT UTILIZING VARIOUS DILUTION RATIOS, GENERATED NON REPRODUCIBLE RESULTS WITHIN THE NORMAL REFERENCE RANGE. THE SAMPLE WAS SENT TO AN OUTSIDE LABORATORY WHERE IT WAS TESTED USING AN UNKNOWN ALTERNATIVE METHODOLOGY. THIS REPEAT RESULT WAS LOWER AND WITHIN THE NORMAL REFERENCE RANGE OF THE ASSAY. THE PATIENT SAMPLE WAS ALSO DISPATCHED TO BECKMAN COULTER INC. CUSTOMER PRODUCT LINE SUPPORT FOR EVALUATION. BECKMAN COULTER INC. INVESTIGATION IS CURRENTLY IN PROGRESS. NO PATIENT SPECIFIC INFORMATION, SAMPLE COLLECTION/HANDLING INFORMATION OR INSTRUMENT SYSTEM INFORMATION WAS PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXL 600 ACCESS® IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS VITAMIN B12 REAGENT