BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2836542 · Received November 16, 2012

    Report

    Report Number
    2050012-2012-01861
    Event Type
    Malfunction
    Date Received
    November 16, 2012
    Date of Event
    October 20, 2012
    Report Date
    October 20, 2012
    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
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REVIEW OF THE CUSTOMER'S ATTACHED DATA, THE CORRECT CHEMISTRY THAT THE CUSTOMER RAN WAS CR-E, NOT CR-S AS DESCRIBED IN THE ORIGINAL REPORT.

    Additional Manufacturer Narrative · 1

    CONTROLS WERE RUN BEFORE AND AFTER THE INCIDENT AND THE RESULTS ARE WITHIN THE (B)(4) STANDARD DEVIATION (SD) RANGE. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THE FSE PERFORMED A PREVENTIVE MAINTENANCE (PM) "A" KIT INSTALLATION AND MONITORED THE INSTRUMENT FOR CREATININE FLYERS FOR FIVE (5) DAYS AND THERE WAS NO INCIDENT OF CREATININE FLYER PRODUCED. FAILURE MODE IS UNKNOWN. THE PM "A" KIT INSTALLATION THAT SERVICE PERFORMED, INVOLVED REPLACEMENT OF MULTIPLE HARDWARE COMPONENTS, RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    THIS IS A FOLLOW UP REPORT.UPDATED INFORMATION:UPON REVIEW OF THE CUSTOMER'S ATTACHED DATA, THE CORRECT CHEMISTRY THAT THE CUSTOMER RAN WAS CR-E, NOT CR-S AS DESCRIBED IN THE ORIGINAL REPORT. CR-E REAGENT IS USED TO MEASURE THE CREATININE CONCENTRATION BY AN ENZYMATIC METHOD; WHEREAS CR-S REAGENT IS USED TO MEASURE THE CREATININE CONCENTRATION BY MODIFIED RATE (B)(4) METHOD (MEASUREMENT OF SERUM CREATININE).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) IN REGARDS TO OBTAINING A FALSE LOW CREATININE (CR-S) RESULT OF 10.5 UMOL/L THAT WAS GENERATED ON THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE CUSTOMER RERAN THE SAMPLE ON THE SAME INSTRUMENT AND OBTAINED A HIGHER RESULT OF 68.2 UMOL/L. THE FALSE LOW RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER RAN A PRECISION RUN OF 20 REPLICATES AND THE RESULTS CORRELATE WITH THE HIGHER VALUE OF 68.2 UMOL/L. NO CHANGE TO PATIENT TREATMENT OR DIAGNOSIS OCCURRED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER INC. DXC 600I N/A

    Patients

    Seq Age Sex Outcome Treatment
    1