BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2114177 · Received June 6, 2011

    Report

    Report Number
    2050012-2011-02152
    Event Type
    Malfunction
    Date Received
    June 6, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 5, 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
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE URINE DRUGS OF ABUSE SAMPLES. CUSTOMER DID NOT INDICATE ANY ISSUES WITH CALIBRATION OR QC. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND FOUND THAT THE CHEMISTRY CARTRIDGE (CC) REAGENT AND THE CC SYRINGES WERE LOOSE. THE FSE ALSO FOUND THAT THE REAGENT PROBE B CUVETTES WERE GENERATING DIRTY CUVETTE MESSAGES. CUSTOMER STATED THAT THE INSTRUMENT WAS GENERATING "CUVETTE NOT DRY" ERROR MESSAGES WHEN THE FSE ARRIVED. THE FSE REPLACED THE REAGENT PROBE B AND PERFORMED ALL CC SIDE ALIGNMENTS. THE ROOT CAUSE APPEARS TO BE HARDWARE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) STATING THAT THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER GENERATED THREE (3) FALSE NEGATIVE DRUGS OF ABUSE PATIENT SAMPLES THAT WERE NOTICED BY THE CUSTOMER. RERUNS WERE PERFORMED ON AN ALTERNATE INSTRUMENT AND RESULTED IN POSITIVE RESULTS AND WERE REPORTED OUT. PATIENT TREATMENT WAS NOT AFFECTED AS THE CUSTOMER RERUNS THE SAMPLES ON ALTERNATE INSTRUMENTS 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 15 YR