BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL® DXC 600I SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2461619 · Received February 20, 2012

    Report

    Report Number
    2050012-2012-00506
    Event Type
    Injury
    Date Received
    February 20, 2012
    Date of Event
    January 26, 2012
    Report Date
    January 26, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JGJ
    PMA / PMN Number
    K060256
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE OBSERVED THAT THE SAMPLE MIXER STATION HAD A PINCHED O-RING CAUSING CARRYOVER FROM THE CC SAMPLE MIXER. THE FSE REPLACED THE WASH STATION. THE FSE VERIFIED THE REPAIRS PER ESTABLISHED PROCEDURES INCLUDING PERFORMING A CARRYOVER TEST. THIS MDR IS RELATED TO MDR 2050012-2012-00503 WHICH HAS BEEN REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT AN ERRONEOUS RESULT FOR MAGNESIUM FOR ONE (1) PATIENT SAMPLE ASSAYED WITH MAGNESIUM REAGENT ON A UNICEL DXC 600I SYNCHRON CHEMISTRY ANALYZER. THE ERRONEOUS MAGNESIUM RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. DUE TO THE ELEVATED RESULT, THE PATIENT WAS SENT TO THE EMERGENCY ROOM. THE CUSTOMER REPORTED THAT THE PATIENT'S MAGNESIUM WAS REASSAYED AT THE EMERGENCY ROOM ON ANOTHER ANALYZER. THE MAGNESIUM RESULT OBTAINED AT THE EMERGENCY ROOM WAS NORMAL. THE PATIENT DID NOT RECEIVE ANY TREATMENT ASSOCIATED WITH THE ORIGINAL ERRONEOUS MAGNESIUM RESULT. THE CUSTOMER REPORTED THAT QUALITY CONTROL RESULTS WERE RECOVERING WITHIN THE LABORATORY'S ESTABLISHED RANGES AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I SYNCHRON® CHEMISTRY ANALYZER DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JGJ BECKMAN COULTER, INC. DXC 600I NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other MAGNESIUM REAGENT