BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2905433 · Received January 9, 2013

    Report

    Report Number
    2122870-2013-00002
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 15, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    CDD
    PMA / PMN Number
    K023764
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    QC RECOVERY WAS WITHIN THE LABORATORY'S ESTABLISHED RANGES ON THE DATES OF THE EVENT. CALIBRATION CURVE PERFORMED ON (B)(4) 2012 SHOWS ALL LEVELS OF CALIBRATORS PASSING WITH ACCEPTABLE % CVS. NO ERRORS WERE POSTED TO THE ANALYZER'S EVENT LOG AT THE TIME OF TESTING. THE SAMPLES WERE COLLECTED INTO 10.0 ML BECTON DICKINSON GOLD TOP SERUM SEPARATOR TUBES AND CENTRIFUGED AT 3,000 RPMS FOR 10 MINUTES. NO VISIBLE SAMPLE INTEGRITY ISSUES WERE NOTED. A BECKMAN COULTER INC., FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE NOTED PRECISION ISSUES TO BE ASSOCIATED WITH PIPETTOR # 3. THE FSE PERFORMED A DRY/WET AND A CARRYOVER TESTING FOR THE ASSAY AND PIPETTOR # 3 FAILED THE WET PORTION OF THE ULTRASONICS LEVEL SENSE SERVICE ASSAY. THE FSE REPLACED THE PIPETTOR # 3 TRANSDUCER HOUSING AND PROBE TIP. THE FSE PRIMED THE SYSTEM AND REPEATED THE ULTRASONIC DRY/WET LEVEL SENSE SERVICE ASSAY AND NOTED ALL PIPETTORS TO BE PASSING WITHIN INSTRUMENT SPECIFICATIONS. HARDWARE VERIFICATION PROCEDURES INCLUDING A SYSTEM CHECK, QC, AND PRECISION TESTING WERE PASSING WITHIN ASSAY'S/INSTRUMENT'S SPECIFICATIONS FOLLOWING THE SERVICE VISIT A HARDWARE MALFUNCTION IS THE LIKELY CAUSE OF THIS EVENT AS THE FSE NOTED THE PRECISION ISSUES TO BE ASSOCIATED WITH PIPETTOR # 3 AND REPLACED THE TRANSDUCER HOUSING AND PROBE TIP TO RESOLVE THE ISSUES FOR THE CUSTOMER.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BEC) TO REPORT THAT THEY OBTAINED ERRATIC (IMPRECISE) VITAMIN B12 RESULTS, BOTH WITHIN AND ABOVE THE NORMAL REFERENCE RANGE, FOR 3 PATIENTS USING THE LABORATORY'S UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. BASED ON CUSTOMERS PROVIDED DATA, REPEAT VITAMIN B12 RESULTS WERE OUTSIDE THE PRECISION CLAIMS (B)(4) AS STATED IN THE ASSAY'S INSTRUCTION FOR USE (IFU). INITIAL RESULTS WERE NOT RELEASED OUTSIDE THE LABORATORY AS ALL REPEAT TESTING WAS COMPLETED PRIOR TO RELEASE; THEREFORE, THERE WAS NO CHANGE TO, OR IMPACT ON, PATIENT TREATMENT. THIS REPORT COVERS THE EVENT OCCURRED ON (B)(6) 2012. REPORT #: 2122870-2013-00003 IS BEING SUBMITTED FOR THE EVENT OCCURRED ON (B)(6) 2012 AT THIS CUSTOMER SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11700 UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE CDD BECKMAN COULTER INC. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1