BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 880I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 2180993 · Received July 1, 2011

    Report

    Report Number
    2050012-2011-02766
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    January 4, 2010
    Report Date
    January 4, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    CGA
    PMA / PMN Number
    K060256
    Removal / Correction Number
    Z-2388-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) VISITED THE FACILITY AND EXAMINED THE SYSTEM. THE FSE REPLACED THE GLUCOSE MODULE ASSEMBLY THEN PERFORMED QUALITY CONTROL AND PRECISION TESTS. THE QUALITY CONTROLS AND PRECISION TESTS WERE ACCEPTABLE. ALTHOUGH PARTS WERE REPLACED, THE SPECIFIC ROOT CAUSE OF THIS SINGLE EVENT REMAINS UNK, ACCORDINGLY, NO CONCLUSION CAN BE DRAWN. THE FSE ALSO OBSERVED DURING THE SYSTEM EVAL THAT EXCESS DISTILLED WATER WAS FILLING THE CUP DURING A WATER PRIME; THE FSE PERFORMED MAINTENANCE RELATED TO THIS ASSEMBLY, HOWEVER, THIS ASSEMBLY IS NOT RELATED TO THE GLUCOSE EVENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4), 2008 AND (B)(4), 2010 FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A LOW GLUCOSE RESULT WAS GENERATED BY THE UNICEL DXC 880I SYNCHRON ACCESS CLINICAL SYSTEM FOR ONE PT. THE SYSTEM GENERATED CRITICAL RERUN FEATURE WAS TRIGGERED AND RETURNED A RESULT WITHIN EXPECTATION. QUALITY CONTROLS WERE WITHIN ACCEPTABLE RANGE. THE INITIAL LOW RESULT WAS NOT REPORTED OUT OF THE LABORATORY. THE SAMPLE WAS RETESTED SEVERAL TIMES AND RETURNED A HIGHER RESULT. THERE WAS NO CHANGE TO THE PT'S CARE OR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 880I SYNCHRON ACCESS CLINICAL SYSTEM CGA BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK