BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL® DXI 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2800781 · Received October 23, 2012

    Report

    Report Number
    2122870-2012-01809
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    September 27, 2012
    Report Date
    September 27, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2012, A FIELD SERVICE ENGINEER (FSE) WAS ON SITE TO VERIFY HARDWARE PERFORMANCE. THE FSE FOUND THE ULTRASONICS TRANSDUCER VOLTAGE OUT OF SPECIFICATIONS (197 ± 3.0 VAC). THE INITIAL VOLTAGE READING WAS 238, WHICH WAS ADJUSTED TO 197. THE FSE DEEMED THE INCREASED ULTRASONIC TRANSDUCER VOLTAGE WAS THE LIKELY CAUSE OF THE EVENT AS THE LABORATORY HAS REPORTED NO ADDITIONAL ERRONEOUS ACCUTNI RESULTS FOLLOWING THE ADJUSTMENT OF THE VOLTAGE TO BE WITHIN INSTRUMENT SPECIFICATIONS. FAILURE MODE OF THIS EVENT IS LIKELY A HARDWARE MALFUNCTION. THE FOLLOWING MDRS ARE ASSOCIATED WITH THIS EVENT: 2122870-2012-01820

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED AN ERRONEOUSLY ELEVATED ACCUTNI RESULT (0.31NG/ML) WITHIN THE RISK STRATIFICATION ON ONE PATIENT WHICH WAS GENERATED BY THE UNICEL DXI 600I SYNCHRON ACCESS CLINICAL SYSTEM ON (B)(6) 2012. THE ELEVATED ACCUTNI RESULT WAS REPORTED OUT OF THE LABORATORY AND THE PATIENT WAS TRANSFERRED TO AN ALTERNATE CARDIAC CARE FACILITY AS A RESULT. ON THE MORNING OF(B)(6) 2012, THE PATIENT'S SAMPLE WAS RETESTED ON THE SAME UNIT (TWICE) AS WELL AS ON AN ALTERNATE METHODOLOGY ((B)(4)). THE REPEAT TESTING GENERATED A RESULT OF 0.03 NG/ML AND 0.03 NG/ML ON THE DXI 600I AND 0.00 ON THE DADE STRATUS. BOTH REPEAT RESULTS WERE WITHIN THE NORMAL REFERENCE RANGE. PATIENT DEMOGRAPHIC WAS NOT PROVIDED BY THE CUSTOMER. THE CUSTOMER REPORTED THE SAMPLE WAS DRAWN ON-SITE BY AN INDIVIDUAL TRAINED TO PROPERLY INVERT THE TUBE FOLLOWING COLLECTION INTO A GEL SEPARATOR PLASMA TUBE, WAS A GOOD QUALITY SAMPLE, AND WAS ANALYZED FROM THE PRIMARY TUBE THROUGH THE ANALYZER'S CLOSED TUBE ALIQUOTTER (CTA). NO ADDITIONAL SAMPLE PROCESSING INFORMATION WAS PROVIDED. ALL SYSTEM PARAMETERS (INCLUDING QC (WHICH WAS RUN BEFORE AND AFTER THE EVENT) CALIBRATION, AND SYSTEM CHECKS WERE PERFORMING WITHIN ASSAY/INSTRUMENT SPECIFICATIONS. UNIT OF MEASURE WAS NOT PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization