BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN RUBY ANALYZER

    MDR report key: 2151865 · Received July 6, 2011

    Report

    Report Number
    2919069-2011-00511
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 13, 2011
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K061667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    NO PATIENT INVOLVEMENT; (B)(4) SMOKING. A FIELD SERVICE ENGINEER IDENTIFIED THE CELL-DYN RUBY POWER SUPPLY ASSEMBLY AS THE SOURCE OF THE SMOKE. THE POWER SUPPLY ASSEMBLY WAS REPLACED AND THE INSTRUMENT WAS RETURNED INTO AN OPERABLE STATUS. THE INVESTIGATION PERFORMED FOUND THE RETURNED CELL-DYN RUBY POWER SUPPLY TO BE INOPERATIVE, COVERED WITH SIGNS OF SMOKE INTERNALLY AND EXTERNALLY. LINT WAS OBSERVED INSIDE THE POWER SUPPLY ASSEMBLY. THE PROBABLY CAUSE OF THE SMOKE REPORTED BY THE CUSTOMER MAY BE RELATED TO THE EXCESSIVE LINT FOUND INSIDE THE UNIT, POSSIBLY DUE TO AMBIENT CONDITIONS, I.E. INSTRUMENT LOCATION WITHIN THE LAB AND/OR FILTERS ON THE FAN NOT BEING CLEANED PROPERLY DURING MAINTENANCE. BASED ON THE INVESTIGATION AND EVENT DETAILS, NO PRODUCT DEFICIENCY WAS IDENTIFIED WITH THE CELL-DYN RUBY INSTRUMENT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED WHILE RUNNING THE CELL-DYN RUBY, NOISE WAS HEARD COMING FROM THE BACK OF THE ANALYZER AND SMOKE WAS OBSERVED. THE INSTRUMENT WAS TURNED OFF BUT WHEN TURNED ON AGAIN, AN ERROR WAS GENERATED (NOT PROVIDED). SERVICE WAS DISPATCHED TO INSPECT THE INSTRUMENT. THERE WAS NO REPORT OF INJURY DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN RUBY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1