BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2606005 · Received June 8, 2012

    Report

    Report Number
    2122870-2012-01411
    Event Type
    Malfunction
    Date Received
    June 8, 2012
    Date of Event
    May 14, 2012
    Report Date
    May 14, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE ON (B)(4) 2012 FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) IDENTIFIED A KINKED SUBSTRATE PROBE AND A DAMAGED PERI PUMP INNER SHAFT. THE FSE PERFORMED MAJOR PREVENTIVE MAINTENANCE ACTIVITIES ON THE INSTRUMENT AND REPLACED THE PERI PUMP. THE FSE PERFORMED ALL NECESSARY TESTING AND RELEASED THE INSTRUMENT BACK TO THE CUSTOMER. IN CONCLUSION, HARDWARE IS THE MOST LIKELY CAUSE OF THIS EVENT. ASSOCIATED MDRS: 2122870-2012-01411 AND 2122870-2012-01418.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ERRONEOUS CARDIAC TROPONIN (ACCUTNI) AND/OR IMPRECISE CREATINE KINASE-MB ISOENZYME (CK-MB) RESULTS WERE GENERATED ON A UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR MULTIPLE PATIENTS ACROSS TWO DAYS. THIS REPORT REPRESENTS THE GENERATION OF ELEVATED ERRONEOUS CARDIAC TROPONIN (ACCUTNI) RESULTS AND IMPRECISE CREATINE KINASE-MB ISOENZYME (CK-MB) RESULTS GENERATED FOR THREE PATIENTS ON (B)(6) 2012. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED PATIENT DATA INDICATED THE INVOLVEMENT OF TWO PATIENTS WITH ELEVATED INITIAL ACCUTNI RESULTS WITHIN THE RISK STRATIFICATION RANGE OF THE ASSAY. ONE OF THE PATIENTS ALSO POSSESSED A CK-MB RESULT WITHIN THE NORMAL REFERENCE RANGE OF THE ASSAY. UPON REPEAT ON THE SAME INSTRUMENT, BOTH PATIENTS' REPEAT ACCUTNI RESULTS WERE LOWER AND WITHIN THE NORMAL REFERENCE RANGE OF THE ASSAY. THE PATIENT'S REPEAT CK-MB RESULTS WAS LOWER, WITHIN THE NORMAL REFERENCE RANGE OF THE ASSAY BUT COLLECTIVELY THE RESULTS EXCEEDED THE PRECISION CLAIMS OF THE ASSAY. A THIRD PATIENT WAS VERBALLY COMMUNICATED BY THE CUSTOMER AS ALSO HAVING ELEVATED ACCUTNI AND IMPRECISE CK-MB RESULTS HOWEVER THIS PATIENT'S DATA WAS NOT PROVIDED BY THE CUSTOMER. THE ERRONEOUS/IMPRECISE ACCUTNI/CK-MB RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY AND HENCE THERE WAS NO DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. THE SAMPLES WERE HEPARIN SAMPLES WHICH WERE CENTRIFUGED PRIOR TO TESTING. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED INSTRUMENT ASSAY PERFORMANCE DATA INDICATED THAT BOTH ASSAYS GENERATED ACCEPTABLE CALIBRATION CURVES PRIOR TO THE EVENT. A SYSTEM CHECK PERFORMED ON (B)(6) 2012 FAILED DUE TO SUBSTRATE VARIANCE HOWEVER PASSED ON (B)(6) 2012 AFTER BECKMAN COULTER INC. TECHNICAL SERVICE WAS PROVIDED. ASSAY QUALITY CONTROL RESULTS WERE ACCEPTABLE ON (B)(6) 2012 PRIOR TO THE EVENT HOWEVER LOW LEVEL ACCUTNI QUALITY CONTROLS RESULTS FAILED AFTER THE ERRONEOUS RESULTS WERE GENERATED THE ACCUTNI REAGENT AND CALIBRATOR LOT ASSOCIATED WITH THIS EVENT WAS 123055 AND 121451 RESPECTIVELY. THE CK-MB REAGENT AND CALIBRATOR LOT ASSOCIATED WITH THIS EVENT WAS 123055 AND 110053 RESPECTIVELY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1