BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 2416237 · Received January 13, 2012

    Report

    Report Number
    2050012-2012-00066
    Event Type
    Malfunction
    Date Received
    January 13, 2012
    Date of Event
    December 26, 2011
    Report Date
    December 27, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JGS
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, CUSTOMER REPORTED THAT THE DXC 600I INSTRUMENT GENERATED FALSE LOW SODIUM (NA) AND POTASSIUM (K) RESULTS THE DAY BEFORE. CUSTOMER STATED THAT THE RESULTS WERE REPORTED OUT OF THE LAB. CUSTOMER STATED THAT A REPEAT OF THE SAMPLES GAVE HIGHER RESULTS AND REPORTS WERE AMENDED. THE CUSTOMER DID NOT INDICATE HOW MANY PATIENT SAMPLES WERE AFFECTED, AND ONLY PROVIDE DATA FOR ONE PATIENT. TREATMENT WAS NOT INITIATED OR WITHHELD BASED UPON THE ORIGINAL RESULTS REPORTED. CUSTOMER DID NOT SUPPLY QUALITY CONTROL INFORMATION FROM BEFORE THE EVENT, AND QUALITY CONTROL AFTER TROUBLESHOOTING WAS WITHIN LAB-ESTABLISHED RANGES. SERVICE WAS NOT INITIATED. THE CUSTOMER RESOLVED THE ISSUE BY CLEANING THE MODULAR CHEMISTRY SAMPLE PROBE AND THE NA AND K ELECTRODE TIPS. NO FURTHER ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JGS BECKMAN COULTER, INC. DXC 600I

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR