BEUDAMED
    FDA Adverse Event Other Summary report: N

    CD 3700 SL

    MDR report key: 769628 · Received October 11, 2006

    Report

    Report Number
    2919069-2006-00079
    Event Type
    Other
    Date Received
    October 11, 2006
    Date of Event
    September 21, 2006
    Report Date
    September 25, 2006
    Manufacturer
    ABBOTT LABORATORIES DIV/ CELLDYN
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE CUSTOMER CONTACTED, THE CUSTOMER TECHNICAL ADVOCATE (CTA) ON 09/25/2006, REGARDING DISCREPANT RESULTS (WBC, RBC, HGB, PLT) ON ONE PATIENT. THE FIRST SAMPLE WAS COLLECTED AT ABOUT 09:30 AND ANALYZED AT 09:54. AN LRI FLAG (LOW REGION INTERFERENCE) WAS GENERATED FOR THE PLATELET RESULT AND A STAINED SMEAR, BUT THE DIFFERENCE BETWEEN THE SMEAR AND RESULTS GENERATED WAS NOT NOTED. RESULTS WERE REPORTED OUT LOW. THE ORIGINAL SPECIMEN WAS RUN LESS THAN 30 MINUTES AFTER COLLECTION AND WAS REPEATED. THE FIRST RESULTS WERE ABOUT HALF OF ACTUAL RESULTS ON ALL PARAMETERS, WHEN REPEATED LATER THE SAME DAY. THE CUSTOMER CONFIRMED ADEQUATE MIXING AND HANDLING PROCEDURE. A SECOND SPECIMEN WAS COLLECTED FROM THE PATIENT ON THE SAME DAY AT ABOUT 20:06, AFTER THE PATIENT WAS GIVEN IV AND MOVED TO THE INTENSIVE CARE UNIT (ICU). REPEAT COLLECTION RESULTS WERE HIGHER. THE CTA DISPATCHED FIELD SERVICE 09/25/2006. FIELD SERVICE VISUALLY INSPECTED THE INSTRUMENT AND RAN A PRECISION TEST IN BOTH OPEN AND CLOSED MODE. PRECISION WAS WITHIN SPECIFICATION. FIELD SERVICE PERFORMED A MULTI-POINT INSPECTION, BUT WAS NOT ABLE TO VERIFY INSTRUMENT ISSUE, AS NO SERVICE WAS NEEDED. THE CUSTOMER STATES THAT ONLY ONE SAMPLE HAD AND ISSUE AND SHE SUSPECTS A SHORT SAMPLE ASPIRATION. FIELD SERVICE REVIEWED ORIGINAL RUN DATA WITH CUSTOMER AND TRAINED CUSTOMER ON PROCEDURE FOR LRI AND NO MPV FLAGS AS PER THE OPERATOR'S MANUAL. NO FURTHER INVESTIGATION WAS REQUIRED AS THE INSTRUMENT FLAGGED RESULTS ON ORIGINAL COLLECTION. THE RECOLLECTED SAMPLE HAD NO FLAGS GENERATED. TRENDING REVIEW: A REVIEW OF COMPLAINT REPORTS FOR THE MONTHS OF JUNE, JULY AND AUGUST 2006 DID NOT INDICATE AND ADVERSE TREND FOR CELL-DYN 3700, LIST NUMBER 02H31-01 FOR THE COMPLAINT ISSUE. LABELING: THE EVENT IS ADDRESSED IN THE CELL-DYN 3700 SYSTEM OPERATOR'S MANUAL, REVISION E SECTION 3: PRINCIPLES OF OPERATION, SYSTEM INITIATED MESSAGES AND DATA FLAGS, PAGE 3-51 (LRI) AND PAGES 3-57 (NO MPV FLAG). SECTION 5: OPERATING INSTRUCTIONS, ROUTINE OPERATION, SAMPLE ANALYSIS, PAGE 5-89. SECTION 11: QUALITY CONTROL; QUALITY CONTROL GUIDE, RUNNING CONTROLS, PAGE 7-15 CELL-DYN 22 TRI-LEVEL CONTROLS PACKAGE INSERT; MIXING AND HANDLING INSTRUCTIONS. CONCLUSION: THE ISSUE WAS RELATED TO ONLY ONE SAMPLE AND ONE PATIENT. THE ISSUE COULD NOT BE REPRODUCED BY FIELD SERVICE. THE CELL-DYN 3700 SL ANALYZER WAS FOUND TO BE PERFORMING TO SPECIFICATION. USER ERROR WITH REGARD TO RELEASING FLAGGED RESULTS CONTRIBUTED TO THE ISSUE.) THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    A CUSTOMER TECHNICAL ADVOCATE (CTA) WAS CONTACTED, WITH REGARD TO THE CELL-DYN 3700 SL ANALYZER GENERATING DISCREPANT RESULTS FOR ONE PATIENT. THE INITIAL RUN GENERATED THE FOLLOWING RESULTS; WBC = 3.53 K/UL, HGB = 6.65 G/DL AND PLT = 70.0 K/UL IN CLOSED MODE OF OPERATION. THE PLATELET RESULT WAS FLAGGED LRI (LOWER REGION INTERFERENCE). THE PATIENT WAS MOVED TO THE INTENSIVE CARE UNIT OF THE HOSPITAL. A NEW SAMPLE WAS DRAWN AFTER AN IV HAD BEEN STARTED, YIELDING THE FOLLOWING RESULTS; WBC = 12.3 K/UL, HGB = 12.4G/DL AND PLT = 130 K/UL WITH NO FLAGS. THE ORIGINAL SAMPLE WAS REPEATED YIELDING; WBC = 7.36 K/UL, HGB = 15.0G/DL AND PLT = 140 K/UL. THE PLATELET RESULT WAS FLAGGED LRI AND THE MPV RESULT WAS SUPPRESSED. ALL SAMPLES WERE DRAWN AND TESTED ON THE SAME DAY. AMENDED RESULTS WERE REPORTED OUT OF THE LAB. NO FURTHER IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD 3700 SL AUTOMATED HEMATOLOGY ANALYZER JJE ABBOTT LABORATORIES DIV/ CELLDYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR