BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2830927 · Received November 13, 2012

    Report

    Report Number
    2122870-2012-01900
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 17, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    LTJ
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) PERFORMED HIGH SENSITIVITY SYSTEM CHECK AND PSA PRECISION TEST ACROSS ALL PIPETTORS. ALL RESULTS PASSED WITHIN THE PUBLISHED SPECIFICATIONS WITH A PERCENT COEFFICIENT OF VARIATION (%CV) OF (B)(4). NO HARDWARE ISSUES WERE NOTED. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER THE ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS. THE PATIENT SAMPLES WERE ANALYZED IN SERUM SEPARATOR TUBES AND INSERT CUPS (FOR SHORT SAMPLES) AND CENTRIFUGED AT 3,000 RPM (REVOLUTIONS PER MINUTE) FOR TEN MINUTES. BETWEEN (B)(6) 2012, QUALITY CONTROL WAS WITHIN THE ACCEPTABLE RANGE FOR LEVELS ONE AND THREE. THE LAST CALIBRATION ON THE INSTRUMENT SHOWED FAILURE ON (B)(6) 2012, AND THE LAST PASSING CALIBRATION WAS ON (B)(6) 2012. THE CUSTOMER NOTED THE ISSUE DID NOT OCCUR ON THE SAME PIPETTOR AND INDICATED SYSTEM CHECKS WERE WITHIN THE ACCEPTABLE RANGE ON THE DAY OF THE EVENT. A DEFINITIVE CAUSE OF THE EVENT IS UNKNOWN. THIS MEDWATCH REPORT IS RELATED TO MDR 2122870-2012-01899.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED IMPRECISE PROSTATE-SPECIFIC ANTIGEN (PSA) RESULTS THAT DID NOT REPRODUCE WITHIN THE LABELED PRECISION CLAIM, FOR FIVE PATIENTS, ON SEPARATE DAYS, INVOLVING THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THIS IS REPORT TWO OF TWO. THE CUSTOMER PROGRAMMED THE INSTRUMENT TO REFLEX TEST ANY PSA RESULTS GREATER THAN 0.00 NG/ML. ALL FIVE PATIENT SAMPLES WERE ANALYZED IN DUPLICATE. THE ERRONEOUS RESULTS WERE NOT RELEASED OUT OF THE LABORATORY. THERE WAS NO PATIENT CONSEQUENCE OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1