BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2110836 · Received June 2, 2011

    Report

    Report Number
    2050012-2011-02086
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    April 29, 2011
    Report Date
    May 2, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED IN THE PRIMARY TUBE AND WAS CLEAR IN APPEARANCE. NO INDICATION OF CALIBRATION OR QC PROBLEMS. NO SERVICE CALL WAS GENERATED OR REQUESTED. INTERNAL ANALYSIS OF DATA RECEIVED FROM THE SAMPLE APPEARS TO SHOW A SAMPLE INTEGRITY ISSUE BUT ROOT CAUSE CANNOT BE CONFIRMED.

    Description of Event or Problem · 1

    BECKMAN COULTER INC., (BCI) CONTACTED THIS POST-MOD GLUCOSE (GLUCM) CUSTOMER VIA THE BCI INTERNAL MONITORING PROGRAM. THE CUSTOMER INDICATED THAT ONE (1) ERRONEOUSLY LOW GLUCM SAMPLE WAS NOTICED WHEN RUNNING IN CRITICAL RERUN MODE, GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE CUSTOMER DID NOT CALL AND COMPLAIN TO BCI ABOUT THIS SAMPLE. THE PATIENT'S GLUCOSE RESULTS YIELDED 53 MG/DL AND 68 MG/DL IN CRITICAL RERUN MODE. RERUNS ON AN ALTERNATE INSTRUMENT YIELDED 59 AND 59 MG/DL AND WAS REPORTED. THE CUSTOMER'S CRITERIA IS 8 MG/DL DIFFERENCE IF RECOVERY IS LESS THAN 110 MG/DL AND 12 MG/DL DIFFERENCE IF ABOVE 110 MG/DL RECOVERY. PATIENT TREATMENT WAS NOT AFFECTED IN REGARD TO THIS EVENT AS THE CUSTOMER RUNS ALL GLUCOSE SAMPLES IN DUPLICATE MODE AND VERIFIES THE RESULTS PRIOR TO REPORTING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1