BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 3200 CS 110V ANALYZER

    MDR report key: 2143251 · Received June 28, 2011

    Report

    Report Number
    2919069-2011-00509
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Report Date
    June 15, 2011
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K972354
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. THE CUSTOMER REQUESTED SERVICE FOR ISSUE RESOLUTION. A FIELD SERVICE REPRESENTATIVE (FSR) CLEANED THE HGB FLOW CELL AND ADJUSTED THE HGB OUTPUT TO RESOLVE THE ISSUE. TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. NO FURTHER INVESTIGATION WAS REQUIRED; THE INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS. BASED ON THE INVESTIGATION AND EVENT DETAILS, NO PRODUCT DEFICIENCY WAS IDENTIFIED WITH THE CELL-DYN 3200 INSTRUMENT. THE ISSUE WAS RESOLVED BY PERFORMING NON-SCHEDULED MAINTENANCE ON THE INSTRUMENT, AS INSTRUCTED IN THE CELL-DYN 3200 SYSTEM OPERATOR'S MANUAL.

    Additional Manufacturer Narrative · 1

    (B)(4): FALSE NEGATIVE RESULT. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED A CELL-DYN 3200 ANALYZER GENERATED A FALSELY DECREASED HEMOGLOBIN RESULT FOR ONE PATIENT SAMPLE. THE CELL-DYN ANALYZER GENERATED AN INITIAL HEMOGLOBIN RESULT OF 6.5 G/DL FOR A PATIENT WHO NORMALLY HAD A HEMOGLOBIN RESULT OF 12.5 G/DL. THE FALSELY DECREASED HEMOGLOBIN RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY AND THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 3200 CS 110V ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1