BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2110815 · Received June 1, 2011

    Report

    Report Number
    2050012-2011-01943
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 6, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER CUSTOMER, QC WAS IN RANGE. QC DATA PROVIDED BY THE CUSTOMER APPEARED ACCEPTABLE. THE CUSTOMER DID NOT REPORT ANY CALIBRATION FAILURES OR SYSTEM ERRORS. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE (B)(6) 2011 AND REPLACED MIXER PADDLES AS ROOT CAUSE OF CARRYOVER FAILURE. PERFORMANCE VERIFICATION TESTING AND PRECISION TESTING WAS THEN ACCEPTABLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRATIC RESULTS FOR GLUCOSE (GLU) AND MAGNESIUM (MG) GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM WHICH WERE NOT REPORTED OUTSIDE THE LABORATORY. THE RESULTS PROVIDED BY THE CUSTOMER ARE SHOWN. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT WITH REGARD TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1