BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN EMERALD

    MDR report key: 3023924 · Received March 27, 2013

    Report

    Report Number
    2919069-2013-00035
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 20, 2013
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K081495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOW TEST RESULTS; NO CONSEQUENCES OR IMPACT TO PATIENT. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. A PRODUCT EVALUATION WAS PERFORMED. A REVIEW OF COMPLAINT TICKETS WHERE THE CELL-DYN EMERALD WAS THE LIKELY CAUSE WAS PERFORMED WITH NO ADDITIONAL COMPLAINTS FOUND. A REVIEW OF THE CELL-DYN EMERALD OPERATOR'S MANUAL (9213300G, AUGUST 2012) ADDRESSES VARIOUS ACTIONS THE CUSTOMER SHOULD TAKE WHEN PATIENT RESULTS ARE SUSPECT. THE CUSTOMER IS DIRECTED TO CONFIRM INSTRUMENT PERFORMANCE BY RUNNING CONTROLS. IF IMPRECISE OR INACCURATE RBC, HGB, OR HCT RESULTS ARE OBSERVED, THE CUSTOMER IS DIRECTED TO PERFORM VARIOUS CORRECTIVE ACTIONS. RESULTS OBTAINED FROM THE SYSTEM SHOULD BE USED WITH OTHER CLINICAL DATA AND OTHER DIAGNOSTIC PROCEDURES. IF THE RESULTS ARE INCONSISTENT WITH CLINICAL EVIDENCE, ADDITIONAL TESTING IS SUGGESTED TO CONFIRM THE RESULT. FIELD SERVICE WAS REQUESTED FOR THIS COMPLAINT AND THE FOLLOWING PARTS WERE REPLACED: THE ELECTROVALVE 2-2 (PART NUMBER 8701686201), THE RBC COUNTING HEAD (PART NUMBER 8701687701, AND TUBING 10 (PART NUMBER 8701681201). BASED ON THE EVENT DETAILS AND INVESTIGATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED WITH THE CELL-DYN EMERALD INSTRUMENT, SERIAL NUMBER (B)(4).

    Description of Event or Problem · 1

    THE CELL-DYN EMERALD ANALYZER IS GENERATING FALSELY DECREASED HEMOGLOBIN (HGB) AND HEMATOCRIT (HCT) RESULTS ON A PATIENT SAMPLE. RESULTS PROVIDED = HGB 6.7G/DL / HCT 20.4%. THE PATIENT WAS SENT TO ANOTHER HOSPITAL WHERE THEY WERE REDRAWN AND RETESTED. RESULTS GENERATED AT THE HOSPITAL ON THIS PATIENT WERE: HGB 14.4G/DL / HCT 42.1%. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125811 CELL-DYN EMERALD GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1