BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 1800 ANALYZER

    MDR report key: 1193603 · Received October 14, 2008

    Report

    Report Number
    2919069-2008-00728
    Event Type
    Malfunction
    Date Received
    October 14, 2008
    Date of Event
    September 17, 2008
    Report Date
    September 18, 2008
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    PMA / PMN Number
    K030513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: PRECISION OF INSTRUMENT WAS IN RANGE. POSSIBLE SAMPLE RELATED ISSUE (MIXING, DRAW TECHNIQUE - FINGERSTICK. POSSIBLE SAMPLE COLLECTION TECHNIQUE OR PROCESSING. THIS CUSTOMER ISSUE WAS INVESTIGATED BY REVIEW OF THE COMPLAINT ISSUE, REVIEW OF THE CELL-DYN 1800 SYSTEM OPERATOR'S MANUAL, REVIEW OF ABBOTT HEMATOLOGY MONOGRAPH - PREVENTION OF PATIENT HEMOGLOBIN ERRORS; (B)(4), AS WELL AS REVIEW OF COMPLAINT INFORMATION ON THE CELL-DYN 1800 PRODUCT. THE CUSTOMER EXPERIENCED DISCREPANT HEMOGLOBIN RESULTS WITH A PATIENT SAMPLE COLLECTED IN A MICROCONTAINER. THE CUSTOMER HAD INDICATED THAT NO TROUBLESHOOTING WAS DONE PRIOR TO CONTACTING CUSTOMER SERVICE AND SUPPORT AND THEY PROVIDED FIFTEEN PAGES OF DATA FOR REVIEW. THE INSTRUMENT HAD BEEN RECENTLY SERVICED FOR QUALITY CONTROL (QC) ISSUES WITH PRECISION AND CALIBRATION PERFORMED AT THAT TIME; ALL QC LEVELS AND PARAMETERS WERE RECOVERING WITHIN ACCEPTABLE LIMITS POST SERVICE. THE CUSTOMER STATED THAT ALL SAMPLES ARE FINGERSTICK TUBES AND ARE RUN IMMEDIATELY UPON COLLECTION. THE CUSTOMER TECHNICAL ADVOCATE (CTA) REFERRED THE CUSTOMER TO THE CELL-DYN 1800, SECTION 5, FOR INFORMATION ON SAMPLE STABILITY AND COLLECTION, INCLUDING CLAIMS FOR MICROCONTAINERS. THE CTA ALSO FAXED THE CUSTOMER A COPY OF EDUCATIONAL MATERIAL HEMOGLOBIN: AN IMPORTANT HEMATOLOGY PARAMETER TO THE CUSTOMER FOR REVIEW AND FURTHER INFORMATION REGARDING SPURIOUS RESULTS. THE CELL-DYN 1800 SYSTEM OPERATOR'S MANUAL (07H80-01, REVISION E) UNDER SECTION 5, OPERATING INSTRUCTIONS, SPECIMEN ANALYSIS, PAGE 5-52, PROVIDES INFORMATION IN REGARDS TO SPECIMEN COLLECTION. IN THE CASE OF MICRO-COLLECTION SPECIMENS, THE MINIMUM VOLUME IS 50UL AND THE OPERATOR IS REFERRED TO THE MANUFACTURER'S PACKAGE INSERT AND (B)(6) FOR CAPILLARY SPECIMENS. THE ABBOTT HEMATOLOGY EDUCATIONAL MONOGRAPH; PREVENTION OF PATIENT HEMOGLOBIN ERRORS; (B)(4) PROVIDES INFORMATION REGARDING PRE-ANALYTICAL ERRORS, SPECIFICALLY, MIXING ERRORS ON PAGE 2 OF 6: WHEN HAND-MIXING A BLOOD SPECIMEN, IT IS ESSENTIAL TO PRODUCE A UNIFORM SUSPENSION OF THE BLOOD CELLS. IF THE SPECIMEN IS INSUFFICIENTLY MIXED, AND A SAMPLE IS TAKEN FROM THE TOP OF THE BLOOD, ERRONEOUSLY LOW HB AND RBC RESULTS ARE GENERATED, ALONG WITH INCREASED WHITE BLOOD CELL (WBC) AND PLATELET (PLT) CONCENTRATIONS. WHEN A SAMPLE IS TAKEN FROM THE BOTTOM OF THE BLOOD TUBE, ERRONEOUSLY HIGH HB AND RBC RESULTS ARE FOUND, WITH LOW WBC AND PLT CONCENTRATIONS. A REVIEW OF THE COMPLAINT TRENDING SYSTEM REPORTS, FOR THE PERIOD (B)(6) 2007 THROUGH (B)(6) 2008, DID NOT INDICATE ANY ADVERSE TREND FOR THE CELL-DYN 18, LIST NUMBER 07H77-01, RELATED TO ISSUES WITH DISCREPANT RESULTS ON FINGERSTICK SPECIMENS. BASED ON THE INVESTIGATION, NO PRODUCT ISSUE WAS IDENTIFIED FOR THE CELL-DYN 1800, LIST NUMBER 07H77-01, FOR ISSUES WITH DISCREPANT RESULTS ON FINGERSTICK SPECIMENS. THIS IS THE FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE CELL-DYN 1800 ANALYZER GENERATED DISCREPANT HEMOGLOBIN RESULT ON ONE PATIENT THAT DID NOT MATCH WITH THE HEMOGLOBIN RESULT GENERATED AT THE REFERENCE LABORATORY. SEE DATA BELOW. HEMOGLOBIN RESULTCELL-DYN 1800 ANALYZER 8.4 G/DLREFERENCE LABORATORY 11.8 G/DLTHERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 1800 ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELLDYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI