BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1883612 · Received October 26, 2010

    Report

    Report Number
    2050012-2010-01056
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 26, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THE EVENT, NA QC RESULTS WERE WITHIN THE LAB'S ESTABLISHED RANGES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND FOUND THAT THE ISE REFERENCE REAGENT HAD BEEN LOADED INCORRECTLY. THE REAGENT WAS LOADED CORRECTLY WHICH RESOLVED THE PROBLEM. AS OF (B)(4) 2010, THERE WERE NO FURTHER CALLS TO THE BCI HOTLINE FOR ISE PROBLEMS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) IN REGARDS TO OBTAINING FALSE LOW SODIUM (NA) RESULTS GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE ER PHYSICIAN QUESTIONED THE LOW NA RESULTS. THE SAMPLES WERE REPEATED ON AN ALTERNATE INSTRUMENT, WHICH PRODUCED HIGHER RESULTS, SHOWING ABOUT A 4% BIAS AND AMENDED REPORTS WERE ISSUED. THE CUSTOMER HAS NOT RECEIVED ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR CONNECTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 600 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1