BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNCHRON CX3 DELTA

    MDR report key: 657235 · Received December 22, 2005

    Report

    Report Number
    2050012-2005-00035
    Event Type
    Other
    Date Received
    December 22, 2005
    Date of Event
    November 28, 2005
    Report Date
    December 22, 2005
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJC
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER REGARDING FALSE LOW POTASSIUM (K) RESULTS FROM MULTIPLE PT(S) GENERATED BY THE SYNCHRON CX3 DELTA INSTRUMENT. AS PER CUSTOMER, THE K RESULTS WERE RANGED FROM 0.5 TO 1.0MMOL/L LOWER THAN THE K RESULTS OBTAINED AT REFERENCE LAB. THE CUSTOMER DID NOT PROVIDE THE ACTUAL K RESULTS, BUT ONLY ONE EXAMPLE. CX3 DELTA K RESULT: 3.1 MMOL/L. REFERENCE LAB RESULT: 4.1 MMOL/L. THE CUSTOMER INDICATED THAT PT(S) WERE GIVEN POTASIUM DUE TO FALSE LOW RESULTS. NO ADDITIONAL INFO REGARDIING THIS EVENT WAS PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON CX3 DELTA CLINICAL CHEMISTRY ANALYZER JJC BECKMAN COULTER, INC. CX3 DELTA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA