BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2851772 · Received November 29, 2012

    Report

    Report Number
    2122870-2012-01956
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    September 22, 2012
    Report Date
    November 1, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE CUSTOMER DID NOT QUESTION SYSTEM PERFORMANCE. MAINTENANCE REVIEW OF ZONE TEMPERATURES INDICATES ALL TEMPERATURES WERE WITHIN SPECIFICATIONS ON (B)(6) 2012. SYSTEM CHECK, PERFORMED ON (B)(6) 2012, FAILED THE WASHED PORTION. THE WASHED PORTION WAS REPEATED THE SAME DAY WITH PASSING RESULTS. NO INSTRUMENT FLAGS WERE NOTED. SERVICE ASSAYS WERE PERFORMED ON (B)(6) 2012 AND PASSED WITHIN SPECIFICATION. A DEFINITIVE CAUSE OF THE EVENT IS UNKNOWN. ALL RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS EVENT: 2122870-2012-01950, 2122870-2012-01951, 2122870-2012-01952, 2122870-2012-01953, 2122870-2012-01954, 2122870-2012-01955, 2122870-2012-01956, 2122870-2012-01957.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED THE CUSTOMER ALLEGED IMPRECISION OF TOTAL THYROXINE (TT4) RESULTS, ON SEPARATE DAYS, INVOLVING THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE INITIAL RESULTS WERE SIGNIFICANTLY LOWER THAN THE REANALYZED VALUES. PATIENT RESULTS WERE NOT IMPACTED AS THE PHYSICIAN RERUNS TESTS AND MAKE AN EXACT DIAGNOSIS. THERE WAS NO PATIENT CONSEQUENCE ASSOCIATED WITH THIS EVENT. THIS IS REPORT SEVEN OF EIGHT.

    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 JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1