BEUDAMED
    FDA Adverse Event Other Summary report: N

    CELL-DYN 1700

    MDR report key: 774963 · Received October 30, 2006

    Report

    Report Number
    2919069-2006-00085
    Event Type
    Other
    Date Received
    October 30, 2006
    Date of Event
    October 2, 2006
    Report Date
    October 3, 2006
    Manufacturer
    ABBOTT LABORATORIES DIVISION/CELL DYN
    Product Code
    JJE
    PMA / PMN Number
    K870233
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: ON 10/03/06, THE CUSTOMER REPORTED DISCREPANT HEMOGLOBIN (HGB) RESULTS ON A PT GENERATED USING A CELL-DYN 1700 ANALYZER. THE SAMPLE TYPE WAS A FINGERSTICK INTO A CAPILLARY TUBE (COATED WITH EDTA) THEN DISPENSED INTO A PEDIATRIC EDTA TUBE. THE HGB RESULT OF THE FIRST RUN WAS 5.2 G/DL, AND THE SECOND RUN WAS 6.5 G/DL. THE CUSTOMER REPORTED OUT THE REPEAT RUN RESULTS. THE PT WAS ADMITTED TO THE HOSP DUE TO THE LOW HGB RESULTS. THE PT SAMPLE WAS REDRAWN AT THE HOSP BY VENIPUNCTURE AND THE RESULTING HGB VALUE WAS 10.7 G/DL. THE CUSTOMER STATES ALL QC WAS IN RANGE, MAINTENANCE IS UP-TO-DATE AND ALL OTHER PT SAMPLES HAD NORMAL RESULT. THE CUSTOMER STATED THAT THE SAMPLE WAS RUN WITHIN A FEW MINUTES AFTER IT WAS DRAWN AND THAT IT WAS A DIFFICULT STICK, HOWEVER THEY GOT THE CONTAINER HALF FULL. THE CUSTOMER CHECKED THE SAMPLE FOR CLOTS PRIOR TO RUNNING IT, AND THERE WERE NO CLOTS IN THE TUBE. THE CUSTOMER RAN THE SAMPLE TWICE AND RAN OUT OF SAMPLE. THE CUSTOMER TECHNICAL ADVOCATE (CTA) INSTRUCTED THE CUSTOMER TO PERFORM A PRECISION STUDY TO FURTHER CHECK THE INSTRUMENT PERFORMANCE. THE CTA EXPLAINED THAT DUE TO THE DIFFICULT STICK, THE SAMPLE MAY HAVE HAD EXCESS TISSUE FLUID THAT WOULD AFFECT THE SAMPLE RESULTS. THE CUSTOMER WAS GOING TO VERIFY PRECISION AND IF NO FURTHER CONTACT BY THE END OF THE BUSINESS DAY THE ISSUE CAN BE CLOSED WITH THE ASSUMPTION THAT PRECISION IS WITHIN SPECIFICATION. THERE WAS NO FURTHER CUSTOMER CONTACT, ISSUE WAS RESOLVED. THE PT DATA WAS REVIEWED AND INDICATES THAT THE FINGERSTICK SAMPLES WERE SHORT SAMPLES/INCOMPLETE ASPIRATION. THE FIRST AND SECOND RUNS HAD MULTIPLE LOWER LIMIT FLAGS GENERATED. THE HOSP RESULTS WERE PROPORTIONATELY HIGHER ON MULTIPLE PARAMETERS INDICATING THAT THE FIRST TWO RUNS WERE SHORT SAMPLES. TRENDING ANALYSIS: A REVIEW OF COMPLAINT REPORTS FOR THE MONTHS OF JULY TO SEPTEMBER 2006 DID NOT INDICATE AN ADVERSE TREND FOR THE CELL-DYN 1700 SYSTEM, LIST NUMBER 03H53-01 FOR THE COMPLAINT ISSUE. LABELING: THE EVENT IS ADDRESSED IN THE CELL-DYN 1700 SYSTEM OPERATOR'S MANUAL, VERSION D, PART NUMBER 9140264: SECTION 3: PRINCIPLES OF OPERATION; OPERATIONAL MESSAGE AND DATA FLAGGING; DISPERSION DATA ALERTS (PAGE 3-23). CONCLUSION: THE DEVICE WAS PERFORMING WITHIN SPECIFICATION. IT WAS CONCLUDED THAT SAMPLING TECHNIQUE AND TESTING PROCEDURE CONTRIBUTED TO THE EVENT. THE PT WAS ADMITTED TO THE HOSP DUE TO THE LOW HEMOGLOBIN RESULT INITIALLY REPORTED. THE PT WAS RETESTED AT THE HOSP YIELDING A HIGHER HEMOGLOBIN RESULT WITH NO FURTHER IMPACT TO PT MANAGEMENT REPORTED. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    A CUSTOMER STATES THAT A PT FINGERSTICK SAMPLE WAS DRAWN INTO A CAPILLARY TUBE COATED WITH EDTA, THEN DISPENSED INTO A PEDIATRIC EDTA TUBE. THE TUBE WAS REPORTED TO BE HALF FULL. THE SAMPLE WAS THEN TESTED USING A CELL-DYN 1700 ANALYZER GENERATING A HEMOGLOBIN RESULT OF 5.2 G/DL. THE SAMPLE WAS REPEATED YIELDING A HEMOGLOBIN RESULT OF 6.5 G/DL WHICH WAS REPORTED. THE PT WAS ADMITTED TO THE HOSP BASED ON THE LOW HEMOGLOBIN RESULTS. THE CUSTOMER STATES THAT IT WAS A DIFFICULT STICK AND THE SAMPLE WAS CHECKED FOR CLOTS PRIOR TO RUNNING IT WITH NO CLOTS DETECTED. THE PT WAS REDRAWN AT THE HOSP (VENIPUNCTURE) YIELDING A HEMOGLOBIN OF 10.7 G/DL. NO FURTHER IMPACT TO PT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 1700 AUTOMATED HEMATOLOGY ANALYZER JJE ABBOTT LABORATORIES DIVISION/CELL DYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 MO Hospitalization