BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 2142027 · Received June 28, 2011

    Report

    Report Number
    2050012-2011-02398
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 31, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE FOR THIS EVENT. THE GLUCOSE MODULE WAS REPLACED. ALTHOUGH REPAIRS WERE MADE TO THE INSTRUMENT BEFORE IT WAS RETURNED INTO SERVICE, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 ERRONEOUS MODULAR GLUCOSE (GLUCM) RESULTS WERE GENERATED ON A UNICEL DXC 800 SYNCHRON SYSTEM FOR THREE PATIENT SAMPLES. THE INITIAL ERRONEOUS RESULTS WERE NOTED WHEN RUNNING IN CRITICAL RERUN MODE AND WERE CONFIRMED ON THE GLUCOSE CARTRIDGE METHOD. ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY, AND HENCE THERE WAS NO DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. SAMPLE COLLECTION/HANDLING INFORMATION, SYSTEM CALIBRATION RESULTS, QUALITY CONTROL RESULTS AND SYSTEM CHECK INFORMATION WAS NOT PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1