BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1844090 · Received September 24, 2010

    Report

    Report Number
    2050012-2010-00802
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Date of Event
    August 25, 2010
    Report Date
    September 24, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE THE EVENT WAS REPORTED TO BCI MANY DAYS LATE, TROUBLESHOOTING WAS NOT PERFORMED. THE CUSTOMER HAD REPLACED THE ELECTRODE PRIOR TO SERVICE ARRIVING. THE SIX MONTHS ON-BOARD LIFE OF THE ELECTRODE HAD EXPIRED. AN EXPIRED ELECTRODE IS A ROOT CAUSE FOR THE EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO AN ERRONEOUSLY LOW GLUCOSE (GLUCM) RESULT OF 18 MG/DL GENERATED BY UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER FOR ONE PATIENT. THE RESULT WAS NOT REPORTED OUT OF THE LABORATORY. SUBSEQUENT TESTING PRODUCED HIGHER RESULTS OF 114 AND 111 MG/DL, WHICH WERE REPORTED. THERE WAS NO EFFECT TO THE PATIENT OR THE USER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1