BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 2202019 · Received August 5, 2011

    Report

    Report Number
    2050012-2011-03929
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    May 7, 2008
    Report Date
    May 7, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JGS
    PMA / PMN Number
    K060256
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT REQUESTED FOR THIS EVENT. THE CUSTOMER WAS ADVISED TO ADDRESS SAMPLE COLLECTION TECHNIQUES WITH THE NURSE/IV TEAM AND SHOW THE RESULTS TO THEM SO THEY CAN SEE WHAT CAN OCCUR WHEN PROTOCOL IS NOT FOLLOWED. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(6) 2008 AND (B)(6) 2010 FOR ADDITIONAL REPORTABLE EVENTS. THIS MDR REPRESENTS EVENT 2 OF 2 REPORTED BY THIS CUSTOMER. THIS MDR IS RELATED TO THE FOLLOWING MDRS THAT HAVE BEEN REPORTED: MDR 2050012-2011-03930.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) TO REPORT THAT THEIR UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM GAVE ERRONEOUS ELECTROLYTE RESULTS FOR A PATIENT SAMPLE THAT WAS DRAWN FROM AN INTRAVENOUS (IV) SITE. THE SODIUM (NA) AND CHLORIDE (CL) RESULTS WERE ERRONEOUSLY HIGH WHILE THE POTASSIUM (K), CALCIUM (CALC), CARBON DIOXIDE (CO2), GLUCOSE (GLUM), UREA NITROGEN (BUNM), AND ALKALINE PHOSPHATASE (ALP) RESULTS WERE ALL ERRONEOUSLY LOW. THE RESULTS WERE REPORTED OUTSIDE OF THE LAB AND DID RESULT IN THE PATIENT BEING ADMITTED TO THE MEDICAL CENTER IN PREPARATION FOR RECEIVING IV K AND CALC. THE MEDICAL STAFF QUESTIONED THE RESULTS AND ANOTHER SAMPLE WAS DRAWN FROM A VENIPUNCTURE SITE. THE SYSTEM GAVE NORMAL RESULTS FOR THE SECOND SAMPLE. THE AMENDED RESULTS WERE REPORTED AND THE PATIENT DID NOT RECEIVE TREATMENT. THE ROOT CAUSE OF THE EVENT WAS DETERMINED TO BE IMPROPER SAMPLE COLLECTION FROM IV SITES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM JGS BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention