BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX® I 725 CLINICAL SYSTEM

    MDR report key: 1802146 · Received August 17, 2010

    Report

    Report Number
    2050012-2010-00554
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    July 27, 2010
    Report Date
    August 13, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE COLLECTED IN EDTA PLASMA TUBES. ON (B)(4) 2010 THE CARTRIDGE WAS CALIBRATED AND QC WAS RUN IMMEDIATELY. ALTHOUGH THE QC SHIFTED UP THE RESULTS WERE WITHIN THE LABS ESTABLISHED RANGES. THE CUSTOMER REPLACED THE REAGENT CARTRIDGES WITH A NEW REAGENT CARTRIDGE. SERVICE WAS NOT REQUESTED SINCE THE NEW REAGENT CARTRIDGE RESOLVED THE ISSUE. A CLEAR ROOT CAUSE CAN NOT BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS HIGH %HEMOGLOBIN A1C (HBA1C) RESULTS GENERATED SYNCHRON LXI 725 CLINICAL SYSTEM. THE RESULTS WERE REPORTED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. A NEW REAGENT CARTRIDGES WERE RELOADED ON THE ANALYZER AND CALIBRATED. QC RESULTS WERE WITHIN ESTABLISHED RANGES. THE INITIAL SAMPLES WHICH HAD BEEN RETAINED FOR ONE WEEK WERE RERUN AND LOWER RESULTS WERE OBTAINED. AMENDED REPORTS WERE ISSUED. PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT.

    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. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1