BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1648432 · Received April 1, 2010

    Report

    Report Number
    2050012-2010-00151
    Event Type
    Malfunction
    Date Received
    April 1, 2010
    Date of Event
    March 5, 2010
    Report Date
    June 24, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JFY
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES WERE COLLECTED IN (B)(6) SST TUBES AND STORED AT ROOM TEMPERATURE. THE SAMPLES WERE CENTRIFUGED AT 4000RPM FOR 5 MINUTES. CONTROLS ARE RUN 3 TO 4 TIMES A DAY. CONTROLS RUN BEFORE AND AFTER THE EVENT WERE WITHIN THE LAB'S ESTABLISHED RANGES. A FIELD SERVICE ENGINEER (FSE) REPLACED THE CREATININE MODULE WHICH RESOLVED THE ISSUE. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT. PLEASE NOTE THAT THIS REPORT IS BEING SENT AS A CORRECTION TO REPORT 2050012-2010-00151. THE INITIAL REPORT WAS SUBMITTED AS A PRODUCT PROBLEM INSTEAD OF AN ADVERSE EVENT.

    Additional Manufacturer Narrative · 1

    SAMPLES WERE COLLECTED IN SARSTEDT SST TUBES AND STORED AT ROOM TEMPERATURE. THE SAMPLES WERE CENTRIFUGED AT 4000 RPM FOR 5 MINUTES. CONTROLS ARE RUN 3 TO 4 TIMES A DAY. CONTROLS RUN BEFORE AND AFTER THE EVENT WERE WITHIN THE LAB'S ESTABLISHED RANGES. A FIELD SERVICE ENGINEER (FSE) REPLACED THE CREATININE MODULE WHICH RESOLVED THE ISSUE. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING FALSELY HIGH CREATININE (CRE) RESULTS GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEMS. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LAB. UPON REPEAT LOWER RESULTS WERE OBTAINED. TREATMENT WAS AFFECTED FOR ONE PATIENT. AMIKACIN TREATMENT WAS HALTED DUE TO THE HIGH CRE RESULT. ONCE THE RETEST RESULT WAS CONFIRMED TO BE LOWERED AND COMPARABLE TO THE PREVIOUSLY KNOWN RESULT, THE AMIKACIN TREATMENT WAS RESUMED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING FALSELY HIGH CREATININE (CRE) RESULTS GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEMS. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LAB. UPON REPEAT LOWER RESULTS WERE OBTAINED. TREATMENT WAS AFFECTED FOR ONE PATIENT. AMIKACIN TREATMENT WAS HALTED DUE TO THE HIGH CREM RESULT. ONCE THE RETEST RESULT WAS CONFIRMED TO BE LOWERED AND COMPARABLE TO THE PREVIOUSLY KNOWN RESULT, THE AMIKACIN TREATMENT WAS RESUMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1