BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 2013354 · Received March 10, 2011

    Report

    Report Number
    2050012-2011-00599
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 8, 2011
    Report Date
    February 10, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON AVAILABLE INFORMATION, THERE WAS CALIBRATION ISSUE OCCURRED ON THIS INSTRUMENT. THE CUSTOMER STATED THAT THE CALIBRATION DISK WAS NOT LOADED WHEN THE HBA1C2 REAGENT WAS LOADED ON THE INSTRUMENT. A FIELD SERVICE ENGINEER (FSE) PERFORMED PRODUCT VERIFICATION TESTING (PVT) AND REPLACED MULTIPLE HARDWARE COMPONENTS. THE FSE ALSO REPLACED NEW HBA1C2 REAGENT AND FRESH CALIBRATORS. AS OF (B)(6) 2011, THE CALIBRATION STATUS IS PASSING SINCE (B)(6) 2011. ROOT CAUSE IS UNKNOWN AT THIS TIME.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING FALSE HIGH % HEMOGLOBIN A1C2 (%HBA1C2) RESULTS GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEMS FOR TWO PATIENTS. ORIGINAL SAMPLES WERE RE-TESTED AND REPEATED RESULTS WERE LOWER FOR BOTH PATIENTS. RESULTS WERE REPORTED OUT OF THE LAB. CUSTOMER DID NOT INDICATE CHANGE TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 800 PRO

    Patients

    Seq Age Sex Outcome Treatment
    1