BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN EMERALD

    MDR report key: 2241925 · Received September 9, 2011

    Report

    Report Number
    2919069-2011-00667
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Report Date
    August 31, 2011
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K081495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 STATED CONTROLS WERE TRENDING HIGH ON HGB AND HCT. FIELD SERVICE WAS DISPATCHED FOR ISSUE RESOLUTION. A FIELD SERVICE REPRESENTATIVE (FSR) CALIBRATED THE INSTRUMENT, CLEANED AND LUBRICATED THE SYRINGE PISTONS, LUBRICATED THE LEAD SCREW, AND BLEACHED THE COUNTING CHAMBERS. THE FSR ADJUSTED THE GAINS AND RAN PRECISION, WHICH PASSED. THE INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE INVESTIGATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER STATED A CELL-DYN EMERALD ANALYZER GENERATED A FALSELY DECREASED HEMOGLOBIN RESULT FOR ONE PATIENT SAMPLE. THE CELL-DYN GENERATED A HEMOGLOBIN RESULT OF 7.2 G/DL. THE SAMPLE WAS SENT TO A REFERENCE LABORATORY WHERE A HEMOGLOBIN RESULT OF 10.6. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1