BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX® I 725 CLINICAL SYSTEM

    MDR report key: 1953322 · Received January 7, 2011

    Report

    Report Number
    2050012-2011-00094
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 10, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER INDICATED THAT QC RESULTS HAVE BEEN ACCEPTABLE. NO SPECIFIC SYSTEM ISSUES WERE NOTED. SERVICE WAS NOT REQUESTED FOR THIS EVENT, AS THIS IS A REAGENT ISSUE. INVESTIGATION INTO ROOT CAUSE OF THIS ISSUE IS ONGOING.

    Additional Manufacturer Narrative · 1

    CUSTOMER INDICATED THAT QC RESULTS HAVE BEEN ACCEPTABLE. NO SPECIFIC SYSTEM ISSUES WERE NOTED. SERVICE WAS NOT REQUESTED FOR THIS EVENT, AS THIS A REAGENT ISSUE. INVESTIGATION INTO ROOT CAUSE OF THIS ISSUE IS ONGOING. THIS FOLLOW UP IS SUBMITTED TO CORRECT TYPO'S OBSERVED IN THE ORIGINAL REPORT. THIS EVENT SHOULD HAVE BEEN FILED AS A PRODUCT PROBLEM AND A MALFUNCTION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING FALSELY POSITIVE RHEUMATOID FACTOR (RF) RESULTS THAT WERE REPORTED OUT OF THE LABORATORY, GENERATED BY THE SYNCHRON LX I 725 CLINICAL SYSTEM. IT IS UNKNOWN IF PATIENT TREATMENT WAS AFFECTED IN THIS EVENT. THE RISK OF SERIOUS INJURY WILL BE ASSUMED UPON RECUR. SEPARATE REPORTS 2050012-2011-00091, 2050012-2011-00092, AND 2050012-2011-00093 HAVE BEEN SUBMITTED FOR THE OTHER PATIENTS ASSOCIATED WITH THIS EVENT, WHICH WERE REPORTED ON DIFFERENT DATES.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING FALSELY POSITIVE RHEUMATOID FACTOR (RF) RESULTS THAT WERE REPORTED OUT OF THE LABORATORY, GENERATED BY THE SYNCHRON LX I 725 CLINICAL SYSTEM. THE RESULTS, PROVIDED BY THE CUSTOMER. IT IS UNKNOWN IF PATIENT TREATMENT WAS AFFECTED IN THIS EVENT. SEPARATE REPORTS 2050012-2011-00091, 2050012-2011-00092, AND 2050012-2011-00093 HAVE BEEN SUBMITTED FOR THE OTHER PATIENTS ASSOCIATED WITH THIS EVENT, WHICH WERE REPORTED ON DIFFERENT DATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® LX® I 725 CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. LX®I 725 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other