BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2080917 · Received May 7, 2011

    Report

    Report Number
    2050012-2011-01440
    Event Type
    Malfunction
    Date Received
    May 7, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 8, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER DID NOT PROVIDE SAMPLE COLLECTION AND STORAGE INFORMATION. QC PRIOR TO THE EVENT WAS WITHIN LAB-ESTABLISHED RANGES BUT ON THE BOTTOM OF THE RANGE. QC AFTER THE EVENT WAS OUT OF RANGE. SYSTEM WAS RECALIBRATED AND CUSTOMER REPLACED THE NA ELECTRODE. SERVICE WAS GENERATED TO EVALUATE THE INSTRUMENT. AS OF 04/22/2011, THERE ARE NO FURTHER ISE-RELATED INCIDENTS REPORTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT THAT THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER WAS GENERATING FALSE LOW NA RESULTS FOR SIX (6) PATIENTS. SAMPLES WERE RETESTED AFTER TROUBLESHOOTING WAS PERFORMED. THE RESULTS WERE HIGHER AND REPORTED. FALSE LOW NA RESULTS WERE NOT REPORTED OUT OF THE LAB AND THERE IS NO AFFECT TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 600 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1