BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELL-DYN 1700

    MDR report key: 755741 · Received August 29, 2006

    Report

    Report Number
    2919069-2006-00068
    Event Type
    Injury
    Date Received
    August 29, 2006
    Date of Event
    August 4, 2006
    Report Date
    August 7, 2006
    Manufacturer
    CELLDYN
    Product Code
    JJE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER TECHNICAL ADVOCATE (CTA) INSTRUCTED THE CUSTOMER TO PERFORM A MANUAL CALIBRATION FACTOR ADJUSTMENT, AS CALIBRATION MAY HAVE BEEN COMPROMISED. THE CTA INSTRUCTED THE CUSTOMER TO CHANGE THE CALIBRATION FACTOR TO 1.0 AND RUN A CALIBRATION VERIFICATION PROCEDURE. AFTER VERIFICATION, PLT (PLATELET) CALIBRATION FACTOR WAS MANUALLY ADJUSTED TO 0.86 WITH THE ASSISTANCE OF THE CTA. THE CUSTOMER WAS USING THE NORMAL CONTROL FOR DAILY PLATELET QUALITY CONTROL. THE CTA INFORMED THE CUSTOMER THAT THE NORMAL CONTROL CANNOT BE USED FOR PLATELETS AND THAT BOTH THE LOW AND HIGH CONTROLS MUST BE IN RANGE PRIOR TO RUNNING PATIENT SAMPLES. THE CUSTOMER MENTIONED THAT THE CONTROLS ARE NOT ALWAYS MIXED PROPERLY. THE CTA INSTRUCTED THE CUSTOMER TO MIX CONTROLS ACCORDING TO THE PACKAGE INSERT INSTRUCTIONS. THE ISSUE WAS RESOLVED BY CLEANING THE APERTURE PLATE AND PERFORMING SUPPLEMENTAL CLEANING AND CALIBRATION. AFTER CALIBRATION, ALL CONTROL RESULTS WERE WITHIN SPECIFICATIONS AND ALL PATIENT RESULTS WERE ACCEPTABLE. THIS ISSUE IS ADDRESSED IN THE CELL-DYN 1700 SYSTEM OPERATOR'S MANUAL, VERSION C (PART NUMBER: 9140264), IN THE FOLLOWING SECTIONS: SECTION 6: CALIBRATION PROCEDURES, CALIBRATION METHODS, AUTO-CAL PROCEDURE-PAGE 6-16; SECTION 6: CALIBRATION PROCEDURES, CALIBRATION METHODS, ENTER FACTOR METHOD-PAGE 6-23; SECTION 9: SERVICE AND MAINTENANCE, AS REQUIRED MAINTENANCE, CLEANING/REPLACING THE APERTURE PLATE-PAGE 9-21; SECTION 9: SERVICE AND MAINTENANCE, SUPPLEMENTAL APERTURE CLEANING-PAGE 9-25; SECTION 11: QUALITY CONTROL, QUALITY CONTROL PROCEDURES, GUIDELINES FOR RUNNING CONTROLS-PAGE 11-3, 11-5; AND THE CELL-DYN CONTROL MATERIAL PACKAGE INSERT (PART NUMBER 9155123V): MIXING AND HANDLING INSTRUCTIONS. THE INVESTIGATION DEMONSTRATED THAT THE CELL-DYN 1700 ANALYZER IS PERFORMING WITHIN ITS INTENDED USE, LABEL CLAIMS, AND SPECIFICATIONS. NO DEFICIENCY RELATED TO THE PERFORMANCE OF THE DEVICE WAS IDENTIFIED. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE CELL-DYN 1700 ANALYZER WAS CALIBRATED WITH ALL CONTROL SAMPLES TESTED READING OUT OF SPECIFICATION HIGH. THE CUSTOMER CONTINUED RUNNING PATIENT SAMPLES AND REPORTED THEM OUT OF THE LAB. SOME OF THE RESULTS WERE QUESTIONED BY A PHYSICIAN (NUMBER UNK) AFTER COMPARING PREVIOUS RESULTS WITH CURRENT RESULTS. BASED ON THE DELTA BETWEEN THE RESULTS, SOME OF THESE PATIENTS WERE ADMINISTERED CHEMOTHERAPY. THE CUSTOMER THEN PROCEEDED TO CALIBRATE THE ANALYZER AGAIN BUT NO CALIBRATION FACTOR WAS GENERATED, JUST CHEVRONS (E.G.>>>>>>). THE CUSTOMER TECHNICAL ADVOCATE ADVISED THE CUSTOMER THAT THE CALIBRATION MAY HAVE SOME HOW BEEN COMPROMISED AND SUGGESTED A NUMBER OF TROUBLESHOOTING PROCEDURES TO TRY. THERE IS NO FURTHER IMPACT TO PATIENT MANAGEMENT REPORTED AND NO FURTHER PATIENT INFORMATION WILL BE MADE AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other CELL-DYN 16 TRI-LEVEL CONTROLS LIST# 99109-01| LOT# 16841| CELL-DYN 17/1800 DILUENT LIST#8H17-04 LOT#4189412