BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN SAPPHIRE ANALYZER

    MDR report key: 2063300 · Received April 19, 2011

    Report

    Report Number
    2919069-2011-00168
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    April 5, 2011
    Report Date
    June 15, 2011
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K051215
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AN ABBOTT FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE AND REPLACED THE ANALYZER'S HEMOGLOBIN REAGENT SYRINGE. SUBSEQUENT INSTRUMENT OPERATIONS AND TEST RESULTS WERE ACCEPTABLE. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. THE CELL-DYN SAPPHIRE ANALYZER OPERATION MANUAL PROVIDES INFORMATION TO ADDRESS THE CUSTOMER'S CURRENT ISSUE. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED. REVIEW OF COMPLAINT TRACKING AND TRENDING; FIELD SERVICE INTERVENTION.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE CELL-DYN SAPPHIRE ANALYZER GENERATED AN INITIAL LOW PATIENT HEMOGLOBIN RESULT OF 7.59 G/DL THAT RETESTED AT 12.40 G/DL. NO SUSPECT RESULTS WERE REPORTED FROM THE LAB. 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