BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2933881 · Received January 29, 2013

    Report

    Report Number
    2050012-2013-00044
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 4, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JGS
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    QC ON THE DAY OF THE EVENT DID NOT EXHIBIT IMPRECISION AND WAS WITHIN THE LAB-ESTABLISHED RANGES. QC WAS NOT RUN AFTER THE EVENT DUE TO THE CALIBRATION FAILING. PREVIOUS RUN PATIENT SAMPLES WERE NOT RE-RUN TO CONFIRM ACCURACY BACK TO THE LAST ACCEPTABLE QC RUN. BEC HOTLINE SUGGESTED THE OPERATOR REPLACE THE NA REFERENCE ELECTRODE, BUT THE OPERATOR DEFERRED THIS TROUBLESHOOTING TO THE DAY SHIFT ON MONDAY (B)(6) 2013 (THIS LABORATORY IS CLOSED ON THE WEEKEND). ON (B)(6) 2013, THE CUSTOMER CONTACTED THEIR BEC FIELD SERVICE ENGINEER (FSE) DIRECTLY. THE FSE REPLACED THE CARBON BRIDGE TO RESOLVE THE ISSUE. FAILURE MODE OF THIS EVENT WAS THE CARBON BRIDGE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER TO REPORT THAT THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM GENERATED FALSE LOW SODIUM (NA) RESULTS FOR APPROXIMATELY TWENTY (20) PATIENTS. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. WHEN THE LOW NA RESULTS WERE NOTICED, THE SAMPLES WERE RE-TESTED ON ANOTHER DXC ANALYZER IN THE CUSTOMER'S LAB AND THOSE RESULTS WERE REPORTED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN THE RESULTS GENERATED IN THIS EVENT, BUT THE CUSTOMER DID NOT PROVIDE. UPON CALLBACK ON (B)(4) 2013, THE CUSTOMER SUPPLIED ONE VERBAL EXAMPLE OF AN ORIGINAL NA RESULT OF 134MMOL/L THAT REPEATED AS 139MMOL/L ON THE OTHER DXC INSTRUMENT. THIS EXAMPLE EXCEEDS THE ASSAY PRECISION CLAIM BY 1MMOL/L. THE CUSTOMER LATER STATED THAT THE RESULTS WERE 9-10MMOL/L LOW. THERE WAS NO DEATH NOR INJURY REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38575 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JGS BECKMAN COULTER DXC 600I NA

    Patients

    Seq Age Sex Outcome Treatment
    1