BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2884701 · Received December 24, 2012

    Report

    Report Number
    2050012-2012-01968
    Event Type
    Malfunction
    Date Received
    December 24, 2012
    Date of Event
    November 26, 2012
    Report Date
    November 26, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2012 AND FOUND FOUR BENT WASH VACUUM PROBES. THE ENGINEER REMOVED AND REPLACED ALL BENT PROBES. (P/N 758493 AND 758498) THE CAUSE OF THE BENT PROBES WAS NOT IDENTIFIED. THE SYSTEM WAS TESTED AND MET SPECIFICATIONS; ISSUE WAS RESOLVED. (B)(4).

    Additional Manufacturer Narrative · 1

    IN ADDITION, THE DEVICE MANUFACTURER DATE WAS NOT INCLUDED IN THE ORIGINAL REPORT. THIS IS ALSO INCLUDED IN THIS FOLLOW UP REPORT. DEVICE MANUFACTURER DATE: 06/27/2008.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING THAT THE CUVETTES WERE WET ON THE INSIDE AND OUTSIDE IN THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER. THE LEAK WAS CONTAINED TO THE INSTRUMENT. NO ERRONEOUS RESULTS WERE GENERATED. NO INJURIES WERE SUSTAINED BY ANY LAB PERSONNEL. LAB PERSONNEL WERE WEARING LAB COATS AND GLOVES DURING THIS EVENT.

    Description of Event or Problem · 1

    THIS IS A FOLLOW UP REPORT. THE ORIGINAL REPORT SUBMITTED ON (B)(4) 2012, LISTS THE INCORRECT AFFECTED INSTRUMENT. THE CORRECT INSTRUMENT AFFECTED IS: UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1