BEUDAMED
    FDA Adverse Event Other Summary report: N

    CELL-DYN 3200 CS 110V

    MDR report key: 925314 · Received October 5, 2007

    Report

    Report Number
    2919069-2007-00183
    Event Type
    Other
    Date Received
    October 5, 2007
    Date of Event
    September 24, 2007
    Report Date
    September 24, 2007
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELL DYN
    Product Code
    GKZ
    PMA / PMN Number
    K972354
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: DISCREPANT PATIENT RESULTS GENERATED USING A CELL-DYN 3200CS ANALYZER. THE CUSTOMER CONTACTED CUSTOMER SERVICE BECAUSE OF INTERMITTENT LOCKUPS- INSTRUMENT WOULD STOP RUNNING, MONITOR ON, LED LIGHTS ON BUT NO RESPONSE TO KEYBOARD. AFTER CYCLING POWER THE ISSUE RECURRED. THE CUSTOMER TECHNICAL ADVOCATE (CTA) HAD THE CUSTOMER: POWER OFF; DISCONNECT THE POWER CORD; RESEAT THE HSSL CABLE; RESEAT THE POWER CABLE; VERIFY GROUND WIRES IN PLACE; THEN POWER UP. WHEN THE CD3200 WAS POWERED UP THE MONITOR WAS OFF AND THE INSTRUMENT WOULD NOT INITIALIZE- ONLY THE FAN WORKED. A FIELD SERVICE VISIT WAS ARRANGED. THEN THE CUSTOMER RELATED ISSUES WITH PATIENT RESULTS THAT HAD OCCURRED THAT DAY WITH THE SAME INSTRUMENT. THE CUSTOMER STATED THE CONTROLS HAD BEEN IN, BUT THE RESULTS FOR PATIENTS WERE UNUSUAL. THESE RESULTS HAD BEEN REPORTED OUT. THE CUSTOMER REPEATED THE SAMPLE ON A SECOND CD3200 AND THE RESULTS WERE DIFFERENT. THEREFORE CORRECTED REPORTS WERE SENT OUT FOR THESE PATIENTS. PHYSICIANS AND NURSES WERE NOTIFIED IMMEDIATELY, THEREFORE TREATMENT WAS NOT WITHHELD, CHANGED OR ADJUSTED BECAUSE OF THE INCORRECT RESULTS. CONTROLS WERE REPEATED AND WERE ERRATIC/FAILED MULTIPLE PARAMETERS - NO DATA PROVIDED FOR THIS. THE INITIAL TEST RESULTS FOR WBC AND PLT SUGGEST THESE VALUES MAY HAVE SHOWN DISPERSIONAL DATA ALERTS (HIGHLIGHTED OR UNDERLINED AS OUT OF RANGE). THE CD3200 SYSTEM OPERATOR'S MANUAL (O6H60-01, REV M), ON PAGES P. 3-27 LISTS THE OPERATIONAL FLAGS AND DATA FLAGS THAT THE INSTRUMENT WILL GENERATE AND RECOMMENDS THAT THE LABORATORY REVIEW CRITERIA SHOULD INCORPORATE THESE ALERTS INTO THE REVIEW CRITERIA. DISPERSIONAL DATA ALERTS (P.3-31) INDICATE A NEED FOR THE OPERATOR TO FOLLOW SOME REVIEW CRITERIA (E.G. REPEAT THE SAMPLE, REVIEW A SMEAR, NOTIFY A PHYSICIAN). THE OPERATOR DID OBSERVE UNUSUAL RESULTS BUT REPORTED OUT THE RESULTS. THE SAMPLES WERE THEN RUN ON A SECOND CD3200 AND CORRECTED RESULTS ISSUED. CONTROLS WERE REPEATED AND WERE ERRATIC/FAILED MULTIPLE PARAMETERS. THE FIELD SERVICE REPRESENTATIVE (FSR) VISITED 09/24/2007. THE FSR FOUND THE NOZZLE ASSEMBLY OF THE WOC FLOW CELL, WAS PARTIALLY OBSTRUCTED, SO THE FLOW CELL WAS CLEANED. THE FSR PERFORMED VERIFICATION PROCEDURES (VP): VP-23, VP-26, VP-27, VP-57. ALL VPS PASSED. THE MONITOR WAS FOUND TO BE INTERMITTENTLY RESPONSIVE, THEREFORE WAS REPLACED WITH A NEW FLAT MONITOR. THE OPERATOR'S MANUAL, ON PAGE 9-9, STATES: OVERDUE MAINTENANCE IS USUALLY INDICATED BY AN INCREASE IN IMPRECISION OF ONE OR MORE OF THE DIRECTLY MEASURED PARAMETERS. THIS INCREASE IS DUE TO CARRYOVER OR DILUTION/SAMPLING INCONSISTENCIES. IF THIS OCCURS ON MORE THAN A RANDOM BASIS, THE APPROPRIATE MAINTENANCE SHOULD BE PERFORMED MORE FREQUENTLY. DIRECTLY MEASURED PARAMETERS ARE WBC, RGB, HGB, PLT. TRENDING: A REVIEW OF REPORTS, FOR THE PERIOD JANUARY 2007 THROUGH JULY 2007, DID NOT INDICATE ANY ADVERSE TREND FOR CELL-DYN 3200, LIST BASE 04H60-01 (WHICH INCLUDES 04H59-01) FOR THE COMPLAINT ISSUE. LABELING: THE EVENT IS ADDRESSED IN THE CELL-DYN 3200 SYSTEM OPERATOR'S MANUAL, 06H60-01, REV M SECTION 3: PRINCIPLES OF OPERATION: OPERATION MESSAGES AND DATA FLAGGIN: INTRODUCTION: PAGE. 3-27 DISPERSIONAL DATA ALERTS PAGE 3-31 SECTION 9: SERVICE AND MAINTENANCE; PREVENTIVE MAINTENANCE SCHEDULE: OVERVIEW: P.9-9. CONCLUSION: DEVICE MAINTENANCE CONTRIBUTED TO THE EVENT AS THE FLOW CELL WAS OBSTRUCTED AFFECTING PATIENT RESULTS. AN INTERMITTENT FAILURE CONTRIBUTED TO INSTRUMENT LOCK-UPS AND EVENTUAL FAILURE OF THE MONITOR. THE ISSUES WERE RESOLVED BY SERVICE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. THIS IS THE FINAL REPORT. END OF REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE CELL-DYN 3200 CS ANALYZER LOCKS-UP INTERMITTENTLY AND STOPS RUNNING. SUBSEQUENTLY THE MONITOR TO THE ANALYZER WENT BLANK. WHEN THE CUSTOMER WAS DESCRIBING THE LOCK-UP ISSUE, THEY ALSO DESCRIBED AN APPARTLY UNRELATED ISSUE WITH DISCREPANT PATIENT RESULTS REPORTED. RESULTS REPORTED WERE; WBC=1.45 K/UL, RBC=1.01 M/UL, HGB=13.3 G/DL, HCT=8.2% AND PLT=1,557/UL. A CORRECTED REPORT WAS SENT OUT IMMEDIATELY WITH THE FOLLOWING RESULTS; WBC=4.5 K/UL, RBC=4.04 M/UL, HGB=13.2 G/DL, HCT=37.8 AND PLT=224/UL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 3200 CS 110V AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELL DYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR LOT NO. 5166212| LIST NO. 3H80-02 CD32/R HGB REAGENT