BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 3791447 · Received May 5, 2014

    Report

    Report Number
    2122870-2014-00338
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 9, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) CLEANED THE ANALYTICAL MODULE AND REPLACED THE TIMING BELT AND REBUILT THE WASH PUMP AND PRECISION PUMP. THE FSE CLEANED THE WASH VALVE AND REPLACED THE PRECISION VALVE AND ULTRASONIC TRANSDUCER AND ASSOCIATED PRINTED CIRCUIT BOARD (PCB) BOARD. THE FSE VERIFIED THE TRANSDUCER TEMPERATURE WAS AT 37.5°C. THE FSE PERFORMED A ROUTINE SYSTEM CHECK AND A HIGH SENSITIVITY SYSTEM CHECK; NO FURTHER ISSUES WERE NOTED. ALL VERIFICATION TESTING PASSED WITHIN PUBLISHED PERFORMANCE SPECIFICATIONS. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. IN CONCLUSION, THE LIKELY CAUSE OF THE EVENT IS ATTRIBUTED TO THE ULTRASONIC TRANSDUCER. THE FSE NOTED AFTER REPLACING THE TRANSDUCER, THE CUSTOMER NO LONGER OBTAINED ERRONEOUS RESULTS. BECKMAN COULTER CONTINUES TO TRACK AND TREND ANY INCIDENT RELATED TO THIS ISSUE. THIS MEDWATCH REPORT IS RELATED TO MDR 2122870-2014-00337.

    Description of Event or Problem · 1

    THE AFFILIATE STATED THE CUSTOMER REPORTED FALSELY ELEVATED INITIAL TROPONIN I (ACCESS® ACCUTNI) PATIENT RESULTS INVOLVING THE UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM. THIS REPORT IS TWO OF TWO REFERENCING THE EVENT DATE NOTED. THE CUSTOMER STATED THE ELEVATED RESULTS WERE RELEASED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN AS THE RESULTS DID NOT CORRELATE WITH THE CLINICAL SYMPTOMS. THERE WAS NO PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER THEN REANALYZED THE PATIENT SAMPLES AND RECOVERED NEGATIVE RESULTS. THE PATIENTS' SAMPLES WERE COLLECTED IN 13X100 MM BECTON DICKINSON (BD) LITHIUM HEPARIN PLASMA TUBES WITH GEL AND CENTRIFUGED AT 3,500 RPM (ROTATIONS PER MINUTE) FOR TEN MINUTES AT 20 DEGREES CELSIUS. NO SAMPLE INTEGRITY ISSUES WERE NOTED. THE CUSTOMER NOTED LEVEL 1 QUALITY CONTROL (QC) WAS OUT OF SPECIFICATION FOLLOWING THE EVENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267717 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1