BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN SAPPHIRE ANALYZER

    MDR report key: 2080101 · Received May 6, 2011

    Report

    Report Number
    2919069-2011-00195
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 28, 2011
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K051215
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ABBOTT CUSTOMER TECHNICAL ADVOCATE (CTA) DISCUSSED THE ISSUE WITH AN ABBOTT FIELD SERVICE ENGINEER (FSE) AND FOLLOWED UP WITH THE CUSTOMER ON (B)(6) 2011. THE CUSTOMER STATED THEY HAVE BEEN RUNNING THE INSTRUMENT WITHOUT ANY ISSUE SINCE THE LOW RESULT WAS GENERATED. THE CTA RECOMMENDED THE CUSTOMER TO CHECK THE ASPIRATION PROBE AS A PRECAUTION AND PERFORM A PRECISION CHECK. THE CTA FOLLOWED UP WITH THE CUSTOMER ON (B)(6) 2011 AND CONFIRMED THAT THE CUSTOMER HAD NO MORE ISSUES. THE CUSTOMER DID NOT REPLACE THE ASPIRATION PROBE AND QUALITY CONTROLS HAVE BEEN WORKING CORRECTLY AND THERE HAVE BEEN NO OTHER PATIENT RESULT RELATED ISSUES. A REVIEW OF THE DATA FROM THE CUSTOMER SITE FOUND THE INITIAL RUN WITH THE LOW RESULTS HAD MULTIPLE PARAMETERS WITH DISPERSIONAL DATA ALERTS (UNDERLINED RESULTS) AND INTERPRETIVE MESSAGES (WHEN A RESULT FALLS OUTSIDE THE APPROPRIATE LIMIT). THE CELL-DYN SAPPHIRE SYSTEM OPERATOR'S MANUAL, PART NUMBER 9140426, REVISION A, CONTAINS INFORMATION TO ADDRESS THE CUSTOMER'S ISSUES IN THIS REGARD. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. BASED ON THE CURRENT INVESTIGATION. A PRODUCT MALFUNCTION HAS NOT BEEN IDENTIFIED FOR THE CELL-DYN SAPPHIRE RELATED TO THE REPORTED ISSUE. REVIEW OF COMPLAINT TRACKING AND TRENDING; ABBOTT CUSTOMER TECHNICAL ADVOCATE/FIELD SERVICE INITIATED TROUBLESHOOTING WITH CUSTOMER INTERVENTION.

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT ONE PATIENT SAMPLE GENERATED INITIALLY LOW RESULTS FOR THE WBC, HEMOGLOBIN AND PLATELET PARAMETERS ON THE CELL-DYN SAPPHIRE ANALYZER (CLOSED MODE OF OPERATION, CM). WHEN THE SAMPLE WAS RETESTED ((BOTH IN CLOSED AND OPEN (OM) MODES OF OPERATION)) RESULTS FELL WITHIN THE LABORATORY'S NORMAL REFERENCE RANGES. NO SUSPECT RESULTS WERE REPORTED FROM THE LAB. WBC(10E9/L): INITIAL (CM): 1.76, RETEST (CM): 72.3, RETEST (OM): 128; HEMOGLOBIN(G/L): 7.21, 113., 154; PLATELET(10E9/L): 7.05, 114., 157. THE CUSTOMER REPORTS THAT NO FURTHER SUCH INSTANCES HAVE OCCURRED SINCE THIS SAMPLE WAS TESTED. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1