BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2252863 · Received September 9, 2011

    Report

    Report Number
    2122870-2011-03679
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    November 28, 2008
    Report Date
    November 28, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    Z-0914-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) SERVICED THE UNIT ON (B)(4) 2008 AND DISCOVERED A CRACK IN THE PERI-PUMP TUBING. THE FSE REPLACED THE PERI-TUBING AND VERIFIED ALL HARDWARE VERIFICATION TESTING PASSED WITHIN SPECIFICATIONS. ON (B)(4) 2008, THE FSE REPLACED THE PERISTALTIC PUMP ASSEMBLY AND INSTALLED NEW PERI-PUMP TUBING. THE FSE VERIFIED ALL HARDWARE VERIFICATION TESTING PASSED WITHIN SPECIFICATIONS. THE UNIT CONFORMED TO THE MANUFACTURER'S PERFORMANCE SPECIFICATIONS. A SYSTEM CHECK PERFORMED ON (B)(4) 2008 PASSED SPECIFICATIONS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF PRODUCT COMPLAINTS CONDUCTED FROM JANUARY 01, 2008 THROUGH OCTOBER 23, 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUS THYROID-STIMULATING HORMONE (TSH), PROSTATE-SPECIFIC ANTIGEN (PSA), TOTAL/FREE PROSTATE-SPECIFIC ANTIGEN (FPSA), RUBELLA IGG, VITAMIN B12, FERRITIN, TESTOSTERONE, THYROGLOBULIN ANTIBODIES (TGAB), AND CORTISOL RESULTS FOR 81 PATIENTS INVOLVING UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THIS REPORT REFERS TO PT NUMBER SIXTY-FIVE. THE CUSTOMER STATED THE UNIT RECEIVED SUBSTRATE DISPENSE ERRORS. THE CUSTOMER PERFORMED QUALITY CONTROL (QC) AND SYSTEM CHECK TO VERIFY SYSTEM PERFORMANCE BUT BOTH TESTS FAILED TO MEET SPECIFICATIONS. THE ERRONEOUS RESULTS WERE RELEASED OUT OF THE LABORATORY AND CORRECTED RESULTS WERE OBTAINED. THERE HAS BEEN NO REPORT OF PT INJURY OR CHANGE IN PT TREATMENT ASSOCIATED WITH THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE UNIT.

    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 61 YR ACCESS FERRITIN| ACCESS HYBRITECH PSA| ACCESS VITAMIN B12| ACCESS HYPERSENSITIVE HTSH| ACCESS RUBELLA IGG