BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN SAPPHIRE ANALYZER

    MDR report key: 1840976 · Received September 22, 2010

    Report

    Report Number
    2919069-2010-00448
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    August 25, 2010
    Report Date
    August 24, 2010
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K051215
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS IN PROCESS. AFOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. OTHER TEXT : AN INVESTIGATION IS IN PROCESS

    Additional Manufacturer Narrative · 1

    (B)(4). IN RESPONSE TO THIS ISSUE AN INVESTIGATION WAS INITIATED TO FURTHER EXAMINE THE CUSTOMER'S OBSERVATION. THE INVESTIGATION INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS AND A REVIEW OF LABELING. A FIELD SERVICE ENGINEER (FSE) INSPECTED AND SERVICED THE CELL-DYN SAPPHIRE ANALYZER. THE FSE REPLACED ALL THE TUBING AND FITTINGS IN THE WBC PATHWAY AND REPLACED THE WBC MIXPOT ASSEMBLY. THERE WERE NO FURTHER ISSUES REPORTED. A REVIEW OF THE COMPLAINT TREND REPORTS FOR THE PERIOD OF (B)(4) 2010 TO (B)(4) 2010 WAS CONDUCTED AND INDICATED THERE WERE NO ADVERSE TRENDS ASSOCIATED WITH THE CUSTOMER'S ISSUE. PRODUCT LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS PROBABLE CAUSES AND CORRECTIONS FOR ERRATIC RESULTS. BASED UPON THE INVESTIGATION, IT HAS BEEN DETERMINED THAT THE CELL-DYN SAPPHIRE ANALYZER, LIST NUMBER 8H00-01, (B)(4) IS PERFORMING AS INTENDED. NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED DISCREPANT WBC RESULTS HAD OCCURRED WITH THREE PATIENT SAMPLES ON THE CELL-DYN SAPPHIRE ANALYZER. PATIENT THREE OF THREE GENERATED AN INITIAL WBC RESULT OF 0.7 WITH A REPEAT RESULT OF 0.3. THE RESULT WAS NOT REPORTED OUT OF THE LABORATORY AND NO IMPACT TO PATIENT MANAGEMENT REPORTED. ALL OF THE WBC PATHWAY TUBING AND FITTINGS AND THE MIXPOT WERE REPLACED. FIELD SERVICE PERFORMED PRECISION AND ENSURED THE CELL-DYN WAS OPERATING WITHIN SPECIFICATIONS. THERE HAVE BEEN NO ADDITIONAL REPORTS OF DISCREPANT WBC RESULTS SINCE SERVICE WAS PERFORMED.

    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 CELL-DYN MIXPOT, (B)(4)