BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX20 PRO CHEMISTRY ANALYZER

    MDR report key: 1945087 · Received January 3, 2011

    Report

    Report Number
    2050012-2011-00029
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    December 3, 2010
    Report Date
    December 3, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K011213
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CUSTOMER, THE QC BEFORE THE EVENT WAS IN CONTROL. QC WAS RUN AFTER THE EVENT AND ALL RESULTS WERE SUPPRESSED LOW. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND CLEANED THE PHOS MODULE OUT WITH 50% BLEACH.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING TWELVE (12) ERRONEOUSLY LOW PHOSPHORUS (PHOS) RESULTS THAT WERE GENERATED BY THE SYNCHRON LX20 PRO CHEMISTRY ANALYZER. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY; HOWEVER, RESULTS WERE REPEATED AND AMENDED REPORTS WERE ISSUED. NO CHANGE WAS MADE TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® LX20 PRO CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. LX20 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1