BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2340051 · Received November 4, 2011

    Report

    Report Number
    2122870-2011-05082
    Event Type
    Malfunction
    Date Received
    November 4, 2011
    Date of Event
    January 5, 2010
    Report Date
    January 5, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS SERUM. QUALITY CONTROL (QC) DATA WAS NOT PROVIDED, BUT ARCHIVE DATA FILE INDICATES THAT QC WAS RUN ONCE DAILY. NO QCF (QC FAILED) FLAGS WERE NOTED. NO SYSTEM CHECK DATA WAS PROVIDED. CUSTOMER DID NOT REPORT ANY EVENT LOG MESSAGES ASSOCIATED WITH THIS EVENT. ON (B)(4) 2010, THE FIELD SERVICE ENGINEER EVALUATED THE ANALYZER. RAN DARK COUNTS CHECK, SYSTEM CHECK, HIGH SENSITIVITY FOAM/NO-FOAM TEST AND CARRYOVER TEST-ALL PASSED. RERAN QC; ALL QC RECOVERED WITHIN LIMITS. SYSTEM CHECK PASSED. FSE REPORTED TO CUSTOMER THAT HE FOUND NO HARDWARE ISSUES. INSTRUMENT WAS VERIFIED AS PERFORMING TO SPECIFICATIONS. ROOT CAUSE WAS NOT DETERMINED. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN JANUARY 1, 2008 AND OCTOBER 23, 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ERRONEOUS LOW ACCESS OSTASE TEST RESULT WAS OBTAINED FOR ONE PT SAMPLE WHEN USING THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE ERRONEOUS LOW TEST RESULTS DID NOT MATCH PREVIOUS TEST RESULTS OBTAINED FOR THIS PT. THE ERRONEOUS LOW TEST RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. REPEAT ANALYSIS WAS PERFORMED WITH THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE TEST RESULTS WERE HIGHER AND MATCHED PREVIOUS TEST RESULTS FOR THE PT. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO PT TREATMENT AS A RESULT OF THIS EVENT.

    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 65 YR CCESS OSTASE