BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXL 600 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2628004 · Received June 25, 2012

    Report

    Report Number
    2122870-2012-01506
    Event Type
    Malfunction
    Date Received
    June 25, 2012
    Date of Event
    May 31, 2012
    Report Date
    June 5, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). SERVICE WAS DISPATCHED TO THE SITE ON (B)(4) 2012 FOR THIS EVENT. THE FIELD SERVICE ENGINEER DISCOVERED THAT THE ASPIRATE TUBING WAS CUT AND LEAKING ONTO THE PERI-PUMP. THIS HAD CAUSED SEVERAL OF THE ROLLERS TO SEIZE. THE FSE REMOVED THE PUMP AND SCRUBBED IT CLEAN. THE FSE ALSO CLEANED THE WASH WHEEL AREA AND INSTALLED NEW ASPIRATE TUBING. THE FSE WAS ABLE TO PRIME THE SYSTEM AND CALIBRATE THE PROBE DRAWBACK AND VERIFY THAT THE SUBSTRATE PUMP WAS OPERATING WITHIN SPECIFICATION AFTER THE NECESSARY REPAIRS. THE FSE PERFORMED A ROUTINE SYSTEM CHECK AND ASSAY QUALITY CONTROL ASSESSMENT WITH NO ISSUES NOTED. THE INSTRUMENT WAS THEN RETURNED BACK INTO OPERATION. THE CUT ASPIRATE PROBE TUBING IS THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ERRONEOUS FREE TOTAL THYROXINE (FRT4), THYROID STIMULATING HORMONE (TSH), FREE T3 (FT3), VITAMIN B12 (VIT B12) AND/OR FOLATE (FOLW) RESULTS WERE GENERATED FROM A UNICEL DXL 600 ACCESS IMMUNOASSAY SYSTEM FOR MULTIPLE PATIENTS. THE ISSUE WAS IDENTIFIED BY THE CUSTOMER UPON THE REPEAT TESTING OF PATIENT RESULTS AFTER COMPLETION OF BECKMAN COULTER INC. SERVICE FOR SUBSTRATE DISPENSE FAILURE ERRORS ON (B)(6) 2012. A BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED INSTRUMENT ASSAY PERFORMANCE DATA INDICATED THAT A QUALITY CONTROL (QC) ASSESSMENT PERFORMED ON THE AFTERNOON OF (B)(6) 2012 RECOVERED WITHIN THE LABORATORY'S ESTABLISHED RANGES. THE CUSTOMER THEN PERFORMED ASSAY QC ON THE DAY OF THE EVENT AND FOUND THAT QC WAS OUT OF CONTROL. SOMETIME AFTER PERFORMING QC THE CUSTOMER BEGAN RECEIVING "SUBSTRATE DISPENSE FAILURE" ERRORS FOR WHICH SERVICE WAS DISPATCHED. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED DATA INDICATED THE INVOLVEMENT OF FOURTEEN PATIENTS WHERE THE INITIAL FREE TOTAL THYROXINE (FRT4), THYROID STIMULATING HORMONE (TSH), FREE T3 (FT3), VITAMIN B12 (VIT B12) AND/OR FOLATE (FOLW) RESULTS WERE ERRONEOUS AND UPON REPEAT, AFTER BECKMAN COULTER INC. REPAIRS TO THE INSTRUMENT, THE REPEAT RESULTS WERE DIFFERENT AND REGARDED AS CORRECT. THE INITIAL, ERRONEOUS PATIENT RESULTS WERE REPORTED OUTSIDE THE LABORATORY HOWEVER THERE WAS NO DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. THE PATIENT SAMPLES WERE INITIALLY TESTED AND REPEAT TESTED FROM THE ORIGINAL SAMPLE TUBES WHICH WERE REFRIGERATED BETWEEN TESTING. THE SAMPLES WERE CENTRIFUGED AT ROOM TEMPERATURE PRIOR TO TESTING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1