BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 2202544 · Received August 5, 2011

    Report

    Report Number
    2050012-2011-04233
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    May 15, 2008
    Report Date
    June 26, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Removal / Correction Number
    Z-0914-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) SERVICED THE UNIT AT THE FACILITY FROM (B)(4) 2008 THROUGH (B)(4) 2008. THE FSE REPLACED THE PERISTALTIC PUMP. THE FSE ADJUSTED THE SAMPLE PUMP BACK LASH AND TIGHTENED THE BELT. THE FSE DISCOVERED DRIED WASH BUFFER ON THREE PINCH ROLLERS AND REPLACED THE PINCH ROLLERS. SYSTEM CHECK TESTING AND QUALITY CONTROL (QC) PERFORMED AFTER THE PERISTALTIC PUMP REPLACEMENT CONFORMED TO SPECIFICATIONS. THE UNIT CONFORMED TO THE ESTABLISHED PROCEDURES AND TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS. THE CUSTOMER COLLECTED SAMPLES IN PLASTIC LITHIUM HEPARIN TUBES WITH GEL. THE SAMPLE WAS SPUN FOR 10 MINUTES AT UNKNOWN ROTATIONS PER MINUTE (RPM). QUALITY CONTROL (QC) WAS WITHIN SPECIFICATIONS PRIOR TO THE EVENT, A SYSTEM CHECK PERFORMED ON (B)(6) 2008 CONFORMED TO SPECIFICATIONS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF PRODUCT COMPLAINTS CONDUCTED FROM (B)(4), 2008 THROUGH (B)(4), 2010 FOR ADDITIONAL REPORTABLE EVENTS. THIS MEDWATCH REPORT IS RELATED TO MDRS: 2050012-2011-04231, 2050012-2011-04232, 2050012-2011-04234.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ELEVATED TROPONIN I (ACCUTNI) RESULTS, ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUTOFF, FOR FOUR PATIENTS INVOLVING UNICEL DCX 600I SYNCHRON ACCESS CLINICAL SYSTEM. THIS IS REPORT NUMBER THREE OF FOUR. IT IS UNKNOWN IF THE ERRONEOUS RESULT WAS RELEASED OUT OF THE LABORATORY. THERE HAS BEEN NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE UNIT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCESS ACCUTNI