BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1943153 · Received December 30, 2010

    Report

    Report Number
    2050012-2010-01787
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 1, 2010
    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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC RESULTS WERE WITHIN ESTABLISHED SPECIFICATIONS BEFORE AND AFTER THE EVENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND REPLACED THE LEVEL SENSE BEAD ON THE SAMPLE PROBE. THE FSE ALSO PERFORMED MODULAR CHEMISTRY (MC) ALIGNMENTS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING TWO (2) ERRONEOUSLY LOW GLUCOSE (GLUC) PATIENT RESULTS THAT WAS OBSERVED WHEN RUNNING IN DUPLICATE MODE GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. DUPLICATES DID NOT MATCH FOR EACH PATIENT. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE RESULTS, PROVIDED BY THE CUSTOMER. PATIENT TREATMENT WAS NOT AFFECTED IN THIS EVENT.

    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