BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2951115 · Received February 8, 2013

    Report

    Report Number
    2122870-2013-00079
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 14, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    CDD
    PMA / PMN Number
    K023764
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS DRAWN ON SITE IN A GEL SEPARATED TUBE. THE SAMPLE WAS PROCESSED ON CUSTOMER'S AUTOMATION LINE AND WAS CENTRIFUGED BY A POWER PROCESSOR. SAMPLE QUALITY INFORMATION WAS NOT PROVIDED. THERE IS NO INFORMATION SUPPLIED IF QC RESULTS WERE PASSING OR FAILING AT THE TIME OF THE EVENT. THE CUSTOMER PROVIDED CALIBRATION RESULTS DATED (B)(6) 2012 AND (B)(6) 2013. BOTH CALIBRATIONS PASSED WITH ACCEPTABLE COEFFICIENT OF VARIATION (%CV) AND RELATIVE LIGHT UNITS (RLUS). A PASSING SYSTEM CHECK DATED (B)(6) 2012 WAS PROVIDED BY THE CUSTOMER. THE EVENT LOG FOR (B)(6) 2012 SHOWED NO SIGNIFICANT INFORMATION. THE EVENT LOG FOR (B)(6) 2013 SHOWED MULTIPLE ERRORS GENERATED, AFTER WHICH, THE CUSTOMER PERFORMED THE DAILY CLEAN WHICH FAILED 3 TIMES, WITH A MESSAGE OF "INSUFFICIENT" SAMPLE". NO INDICATION OF A PASSING CLEAN ROUTINE WAS PROVIDED. THERE IS NO INDICATION THAT SERVICE WAS DISPATCHED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) TO REPORT CONSISTENTLY ELEVATED VITAMIN B12 RESULTS >1500PG/ML AND OVER THE RANGE (OVR) FLAGS FOR ONE FEMALE PATIENT 'IN HER LATE 20'S' USING THE LABORATORY'S UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE PATIENT IS NOT UNDERGOING ANY TYPE OF THERAPY AND HAS NO KNOWN DIAGNOSIS. THE CUSTOMER HAS DILUTED THESE SAMPLES 1:5 AND THE >1500PG/ML (<7500PG/ML) AND OVR FLAGS PERSIST. THE PATIENT WAS RE-DRAWN AND THE SAMPLE WAS SENT TO THE BEC FOR POTENTIAL INTERFERENCE ANALYSIS. BEC INTERNAL TESTING CONFIRMED THE CUSTOMER'S RECOVERY, >1500PG/ML AND OVR FLAGS BOTH AT NEAT AND DILUTED 1:5 (<7500PG/ML) CONCENTRATIONS. SERIAL DILUTIONS (1:10 AND 1:20) WERE PERFORMED. RESULTS OBTAINED WERE EQUAL, DEMONSTRATING THAT THIS SAMPLE DOES NOT DILUTE LINEARLY. PROTEIN BLOCKERS DID NOT DEMONSTRATE A DECREASE IN DOSE RECOVERY, INDICATING THIS SAMPLE IS NOT BLOCKED BY THESE PROTEINS. INTRINSIC FACTOR AB (IF AB) WAS MEASURED INDICATING THE ELEVATED VITAMIN B12 RESULT IS NOT CAUSED BY HIGH LEVELS OF IF AB. THE ELEVATED VITAMIN B12 RESULT HAS BEEN CONFIRMED BY BEC INVESTIGATION. THE CAUSE OF THIS EVENT IS UNKNOWN AT THIS TIME. NO PATIENT PRINTOUTS WERE PROVIDED FROM THE ACCESS 2 ANALYZER, OR FROM THE CUSTOMER'S LAB INFORMATION SYSTEM (LIS). NO REPORTS OF DEATH OR INJURY HAVE BEEN SUBMITTED IN CONNECTION TO THIS EVENT. MDR # 2122870-2013-00078 IS BEING SUBMITTED FOR ELEVATED VITAMIN B12 RESULT OBTAINED ON (B)(6) 2012 FOR THE SAME PATIENT AT THIS CUSTOMER SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55193 UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE CDD BECKMAN COULTER DXI 800 ACCESS WITH SPOT B N/A

    Patients

    Seq Age Sex Outcome Treatment
    1