BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC SYNCHRON ® CLINICAL SYSTEMS

    MDR report key: 2213629 · Received August 16, 2011

    Report

    Report Number
    2050012-2011-04002
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 10, 2011
    Report Date
    July 10, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    CGA
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER VERIFIED SEVERAL PATIENT SAMPLES WITHIN THE SAME SHIFT. CALIBRATION OR QC ISSUES WERE NOT NOTED. CUSTOMER CALIBRATES GLU EVERY 14 DAYS AS SPECIFIED OR USES WITHIN-LOT CALIBRATION FEATURE OF 90 DAYS. A BEC FIELD SERVICE ENGINEER (FSE) DISCOVERED THE CARTRIDGE CHEMISTRY PROBE HEIGHT WAS TO LOW. FSE ADJUSTED AND ALIGNED THE INSTRUMENT. FSE DID NOT REPLACE HARDWARE FSE VERIFIED NO OTHER ANALYTES WERE AFFECTED BY THIS EVENT. ROOT CAUSE APPEARS TO BE THE CC PROBE HEIGHT INCORRECT ALIGNMENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) IN REGARDS TO SEVERAL GLU PATIENT RESULTS WERE ERRONEOUSLY LOW FROM GLU ONE REAGENT CARTRIDGE GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE CUSTOMER HAD 2 CARTRIDGES LOADED ON THE INSTRUMENT SIMULTANEOUSLY. RESULTS FROM OTHER CARTRIDGE WERE CONSIDERED CORRECT. PER CUSTOMER, ALL ORIGINAL RESULTS FROM THIS INSTRUMENT WERE REPEATED ON THEIR LAB'S ALTERNATE INSTRUMENT. THE RESULTS WERE VERIFIED AND THEN REPORTED. NO RESULTS WERE AMENDED. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. CUSTOMER ONLY PROVIDED ONE EXAMPLE. THE RESULTS ARE PROVIDED. CUSTOMER VERIFIED PATIENT TREATMENT WAS NOT AFFECTED BY THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC SYNCHRON ® CLINICAL SYSTEMS DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE CGA BECKMAN COULTER INC. DXC 800P N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR