BEUDAMED
    FDA Adverse Event Summary report: N

    UNICEL® DXC 800 SYNCHRON ® CHEMISTRY ANALYZER

    MDR report key: 1953323 · Received January 7, 2011

    Report

    Report Number
    2050012-2011-00080
    Date Received
    January 7, 2011
    Date of Event
    September 17, 2010
    Report Date
    September 21, 2010
    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

    THE CUSTOMER RECOMMENCED THE USE OF THE MODULAR ASSAY AFTER HAVING THE MODULE DISABLED IN (B)(4) 2010. THE CUSTOMER DID NOT NOTIFY HOTLINE OR FIELD SERVICE TO HAVE THE MODULE VERIFIED FOR USE AGAIN. A BCI FIELD SERVICE ENGINEER (FSE) REPLACED THE UNCLEAN REAGENT SYRINGE WHICH HAD CAUSED THE RELEASE OF BUBBLES INTO THE CUP ASSEMBLY. THE PRECISION RUNS AND QC PERFORMED WITHIN ESTABLISHED SPECIFICATIONS THE ROOT CAUSE FOR THIS EVENT IS THE UNCLEAN REAGENT SYRINGE. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS WITHIN THE DATE RANGE (B)(4) 2010, FOR ADDITIONAL REPORTABLE EVENTS/OCCURRENCES. THIS REPORTABLE EVENT IS RELATED TO PREVIOUSLY SUBMITTED MDR 2050012-2010-01011.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A DISCREPANT DUPLICATE GLUCOSE MODULAR (GLUCM) RESULTS FOR THREE PATIENT SAMPLES GENERATED BY UNICEL DXC 800 SYNCHRON CLINICAL SYSTEM. THE CUSTOMER RUNS PATIENT SAMPLES IN DUPLICATE AND NOTICED THE ORIGINAL SAMPLE DID NOT MATCH THE DUPLICATE. THE ORIGINAL SAMPLE WAS REPEATED ON AN ALTERNATE UNIT WHICH CONFIRMED THE ORIGINAL RUN'S RESULT. PATIENTS 2 AND 3 RESULTS ARE PROVIDED. PATIENT ONE'S RESULTS WERE CAPTURED IN MDR 2050012-2010-01011. THE ERRONEOUS RESULT WAS NOT REPORTED OUT OF THE LABORATORY. PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1