BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 2321019 · Received October 28, 2011

    Report

    Report Number
    2050012-2011-06574
    Event Type
    Malfunction
    Date Received
    October 28, 2011
    Date of Event
    November 5, 2008
    Report Date
    November 7, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER, INC. EXPLAINED THE DATA STREAM TO THE CUSTOMER AND ADVISED THE CUSTOMER TO CONTACT THEIR LAB INFO SYSTEM (LIS) VENDOR. SINCE THE CUSTOMER HAD CONFIGURED THE ANALYZER TO NOT SENT THE "<" OR ">" SYMBOLS TO THE LIS, THE SYSTEM SENT "#######" IN THE RESULT FIELD OF THE DATA STREAM TO THE LIS. SINCE A "<" WAS PART OF THE RESULT, THE SYSTEM INSERTED "LT" (LESS THAN) INTO THE RESULT ERROR FIELD. THE SYSTEM ALSO INSERTED "1" INTO THE OVER RANGE DETECTION AND CORRECTION (ORDAC) FIELD AND "O" INTO THE SYSTEM CODE FIELD OF THE DATA STREAM INDICATING THAT THE RESULT WAS ORDAC. COMBINED WITH THE "LT" IN THE RESULT ERROR FIELD, THE SYSTEM COMMUNICATED TO LIS THAT THE RESULT IS LESS THAN THE LOWER ORDAC RANGE OF 150-488 MG/L. THE LIS WAS LOOKING ONLY IN THE RESULT ERROR FIELDS, AND FAILED TO CHECK THE OTHER NECESSARY FIELDS, THEREBY, INCORRECTLY INTERPRETING THE RESULT SENT BY THE UNICEL DXC 600I SYSTEM. THE LIS DETECTED THE "LT" FLAGGED, AND POSTED A RESULT OF "<10MG/L" WHICH IS THE LOWER REPORTABLE RANGE CONFIGURED BY THE CUSTOMER. AS REVIEWED BY BECKMAN COULTER, INC. THE UNICEL DXC 600I SYSTEM GENERATED A CORRECT RESULT WHICH WAS MISINTERPRETED BY THE LIS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF PRODUCT COMPLAINTS CONDUCTED FROM (B)(4) 2008 THROUGH (B)(4), 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED THE CUSTOMER ALLEGED OUT OF RANGE LOW C-REACTIVE PROTEIN (CRP) RESULT, FOR ONE PT, INVOLVING UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE ERRONEOUS RESULT WAS REPORTED IN LAB INFO SYSTEM (LIS) AS LESS THAN TEN (<10) CRP. THE PT'S SAMPLE HAD BEEN TESTED SEVERAL TIMES AND BLANK RATE HIGH ERRORS WERE OBTAINED. THE ERRONEOUS RESULT WAS RELEASED OUT OF THE LAB. AN AMENDED REPORT WAS RELEASED TO THE HOSP THE FOLLOWING DAY. THERE WAS NO REPORT OF PT INJURY OR CHANGE IN PT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK