BEUDAMED
    FDA Adverse Event Summary report: N

    UNICEL® DXC 880I SYNCHRON® ACCESS® CLINICAL SYSTEM (FULL SYSTEM)

    MDR report key: 2140236 · Received June 26, 2011

    Report

    Report Number
    2050012-2011-02673
    Date Received
    June 26, 2011
    Date of Event
    May 27, 2011
    Report Date
    May 27, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT PROVIDE SAMPLE INFORMATION. QC PRIOR TO THE EVENT WAS WITHIN THE LAB ESTABLISHED RANGES (HIGH END OF THE RANGE). QC AFTER THE EVENT WAS HIGH. QA REVIEWED THE QC VIA PROSERVICE WHICH SHOWS IMPRECISION IN THE DAYS PRECEDING THE EVENT. A BCI FIELD SERVICE ENGINEER REPLACED THE CARBON BRIDGE AND VERIFIED PERFORMANCE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS LOW SODIUM (NA) RESULTS FOR 5 PATIENTS SAMPLES. PATIENT #1 ALSO HAD A LOW CHLORIDE (CL) RESULTS AND PATIENT #2 HAD A HIGH CARBON DIOXIDE (C02) RESULT. THE RESULTS WERE GENERATED BY THE UNICEL DXC 880I SYNCHRON ACCESS CLINICAL SYSTEM. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE REPEATED ON AN ALTERNATE UNIT AND THE RESULTS WERE AMENDED. PATIENT TREATMENT WAS NOT INITIATED OR WITHHELD BASED UPON THE FALSE RESULTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 880I SYNCHRON® ACCESS® CLINICAL SYSTEM (FULL SYSTEM) DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER, JJE BECKMAN COULTER INC. DXC 880I N/A

    Patients

    Seq Age Sex Outcome Treatment
    1