BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1962169 · Received January 17, 2011

    Report

    Report Number
    2050012-2011-00172
    Event Type
    Malfunction
    Date Received
    January 17, 2011
    Date of Event
    December 19, 2010
    Report Date
    December 19, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CUSTOMER, QC BEEN WITHIN ACCEPTABLE RANGE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2010 FOR THIS EVENT. THE FSE REPLACED THE CHEMISTRY CARTRIDGE (CC) SAMPLE SYRINGE BARREL, THE 3-WAY VALVE, AND FLUSHED THE SAMPLE PROBE. THE FSE THEN FOUND TUBING LEAKING BETWEEN THE SAMPLE PROBE AND THE OBSTRUCTION DETECTION TRANSDUCER. THE FSE REPLACED THE TUBING, RE-CALIBRATED THE SYSTEM, AND RAN QC. ALL RESULTS WERE ACCEPTABLE AND THE INSTRUMENT WAS RUNNING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING FALSELY LOW MAGNESIUM (MG) RESULTS THAT WERE GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER INDICATED THAT THE LOW MG RESULTS RANGED <0.1 MMOL/L, WHICH WERE REPEATED ON AN ALTERNATE SYSTEM THAT RECOVERED WITHIN NORMAL RANGE. 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 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1