BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2183603 · Received July 8, 2011

    Report

    Report Number
    2122870-2011-01153
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    February 15, 2008
    Report Date
    February 19, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THAT THESE SAMPLES WERE BOTH FULL DRAWS AND NO FIBRIN WAS NOTED. SAMPLE TYPE AND CENTRIFUGATION DATA WAS NOT SUPPLIED. SYSTEM CHECK AND QUALITY CONTROL DATA WAS NOT SUPPLIED. CUSTOMER ALSO DECLINED THE REQUEST FOR REAGENT INVENTORIES AND STATED THAT THEY DO NOT PACK SHARE. THIS IS A COMPETITIVE ASSAY AND LACK OF REAGENT WOULD RESULT IN VITAMIN B12 RESULTS > HIGHEST CALIBRATOR, 1500PG/ML. ON (B)(4) 2008, THE FIELD SERVICE ENGINEER (FSE) PERFORMED HARDWARE VERIFICATION AND ALL TESTS PASSED SPECIFICATIONS. THE FSE VERIFIED INSTRUMENT PERFORMANCE PER ESTABLISHED PROCEDURES. ROOT CAUSE WAS NOT DETERMINED. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN JANUARY 1, 2008 AND OCTOBER 23, 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS. THIS MDR REPRESENTS EVENT 2 OF 2 REPORTED BY THIS CUSTOMER. THIS MDR IS RELATED TO THE FOLLOWING MDRS THAT HAVE BEEN REPORTED: MDR 2122870-2011-01132.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS ELEVATED TEST RESULTS WERE OBTAINED FOR VITAMIN B12 WHEN USING A UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THERE WERE EIGHT PATIENT SAMPLES WITH ERRONEOUS TEST RESULTS OF >1500 PG/ML. TWO OF THE EIGHT WERE REPORTED OUT OF THE LABORATORY. IT IS UNKNOWN IF THERE WAS ANY AFFECT ON PATIENT CARE. NO REPORTS OF DEATH OR SERIOUS INJURY AS A RESULT OF THIS EVENT. THIS EVENT REPRESENTS EVENT 2 OF 2 EVENTS REPORTED BY THIS CUSTOMER FOR ONE OF THE TWO PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCESS VITAMIN B12 ASSAY