BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 1935625 · Received December 22, 2010

    Report

    Report Number
    2050012-2010-01714
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 24, 2010
    Report Date
    November 29, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    CGA
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN THE ESTABLISHED SPECIFICATIONS. SERVICE CALL WAS NOT REQUESTED. THE ROOT CAUSE FOR THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ONE GLUCOSE (GLU) RESULT GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM THAT DID NOT MATCH WHEN RUN IN DUPLICATE MODE. THE ORIGINAL RESULT WAS 110 AND 95MG/DL IN DUPLICATE MODE. THE ERRONEOUS RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. RERUNS ON THE SAME INSTRUMENT YIELDED 100 AND 99MG/DL. THE CUSTOMER REPORTED OUT 100MG/DL. THERE WAS NO AFFECT TO PATIENT TREATMENT WITH REGARD TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER CGA BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1