BEUDAMED
    FDA Adverse Event Summary report: N

    UNICEL® DXC 800 SYNCHRON ® CHEMISTRY ANALYZER

    MDR report key: 2140237 · Received June 26, 2011

    Report

    Report Number
    2050012-2011-02674
    Date Received
    June 26, 2011
    Date of Event
    April 13, 2011
    Report Date
    May 27, 2011
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE AND QC INFORMATION WERE NOT PROVIDED. THE CUSTOMER STATED ONLY THAT THE QC HAD DROPPED 4-5 MMOL/L LOWER. A 4-5 MMOL/L CHANGE IN CL RESULTS IS WITHIN THE PRECISION OF THE ASSAY. ON (B)(4) 2011, A BCI FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND FOUND EVIDENCE OF IMPROPER SAMPLE HANDLING AND INSUFFICIENT SPIN TIMES. THE SAMPLE INSPECTED ON THE DAY OF THE EVENT HAD CLOTS AND EVIDENCE OF GEL BEING ASPIRATED INTO THE PROBE. FSE INSTRUCTED THE CUSTOMER ON PROPER HANDLING AND THE CAUSES FOR THE EVENT. FSE REPLACED THE ELECTROLYTE INJECTION CUP (EIC) VALVES AND VERIFIED PERFORMANCE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO AN ERRONEOUS LOW CHLORIDE (CL) RESULTS GENERATED BY THE UNICEL DXC 800 SYNCHRON CHEMISTRY ANALYZER. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. WHEN QC SHIFTED LOW, SAMPLES WERE REPEATED AND RESULTS AMENDED. THE CUSTOMER DID NOT PROVIDE INFORMATION ON THE NUMBER OF PATIENT AFFECTED OR PATIENT RESULTS. UNKNOWN IF TREATMENT WAS INITIATED OR WITHHELD BASED ON THE INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 SYNCHRON ® CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1