BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD1800 ANALYZER

    MDR report key: 1080269 · Received July 22, 2008

    Report

    Report Number
    2919069-2008-00642
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    June 26, 2008
    Report Date
    July 2, 2008
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    PMA / PMN Number
    K030513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SILICON TUBING (S1, S2), SAMPLE PROBE, 100UL & 10ML SYRINGE DRIVE. THE CUSTOMER RAN NORMAL QC AS A TROUBLESHOOTING STEP AND WBC, HGB AND HCT WERE WITHIN RANGE. THE ABBOTT CUSTOMER TECHNICAL ADVOCATE (CTA) VERIFIED THE LYSE WAS PROPERLY INSTALLED, THE LYSE SYRINGE FREE OF LEAKS/CRACKS/AIR/POCKETS/BUBBLES. BACKGROUNDS WERE REPORTED TO BE IN RANGE. HOWEVER, THE CTA NOTED THAT THE HGB REFERENCE WAS LOW AT 1770 (RANGE 1800-2200). PER THE CUSTOMER'S REQUEST, A FIELD SERVICE REPRESENTATIVE (FSR) WAS DISPATCHED. THE FSR VISITED IN 2008 AND REPLACED THE 100UL SYRINGE DUE TO OBSERVING AIR BUBBLES. SILICON TUBING, (S1 AND S2), WHICH WAS DIRTY/WORN FROM NORMAL USE WAS ALSO REPLACED. A PRECISION STUDY WAS RUN AND PASSED. THE CUSTOMER REPORTED THE FOLLOWING MONTH THAT THE ISSUE PERSISTED. THE CUSTOMER USES 5ML EDTA TUBES AND AN ELECTRIC MECHANICAL MIXER. THE FSR RETURNED SAME DAY, AND DID A PROBE HEIGHT ADJUSTMENT. VERIFICATION TESTING PASSED SPECIFICATIONS AND PRECISION TESTING SHOWED THE %CV IMPROVED. THE SYRINGE DRIVES WERE OBSERVED TO BE NOISY, THEREFORE THE 100UL AND 10ML SYRINGE PUMP ASSEMBLY WERE LUBRICATED. VERIFICATION PROCEDURES FOR THE SYRINGE DRIVES PASSED SPECIFICATION. THE ISSUE WAS RESOLVED BY REPLACING THE SYRINGE, AS WELL AS ADJUSTMENT OF THE PROBE HEIGHT AND 100UL AND 10ML SYRINGE DRIVES. THE CELL-DYN SYSTEM 1800 OPERATOR'S MANUAL, DESCRIBES THE RULE OF THREE AS A QUICK MATHEMATICAL CHECK TO ENSURE THE PATIENT'S HEMOGLOBIN AND HEMATOCRIT PARAMETERS WERE CONSISTENT. THE HEMATOCRIT IS ROUGHLY THREE TIMES THE HEMOGLOBIN. THIS SIMPLE FORMULA WORKS ONLY ON NORMOCYTIC, NORMOCHROMIC SAMPLES (THAT IS, SAMPLES WITH MCV AND MCHC WITHIN NORMAL LIMITS). IF THE CALCULATED (HGB X 3) = HCT DOES NOT AGREE WITH THE REPORTED HCT, THE SYSTEM COULD BE MISCALIBRATED, MALFUNCTIONING, OR THE SAMPLE HAS PATHOLOGY REQUIRING FURTHER INVESTIGATION (11-4). THE FSR FOUND A WORN SAMPLE SYRINGE AND WORN SILICON TUBING. THE FSR OBSERVED THE SAMPLE SYRINGE HAD BUBBLES IN IT. CLEANING OR REPLACING THE SAMPLE SYRINGE IS AN AS-REQUIRED MAINTENANCE ACTIVITY (9-79 TO 9-83). ADDITIONAL ADJUSTMENT OF THE PROBE HEIGHT AND LUBRICATION OF THE SYRINGE DRIVES ARE FIELD SERVICE ACTIVITIES. REVIEW OF THE DOMESTIC AND INTERNATIONAL COMPLAINTS FROM 2007 THROUGH 2008 DID NOT FIND ANY ADVERSE TREND ON LIST BASE FOR THE COMPLAINT ISSUE. BASED ON THE ABOVE INVESTIGATION, NO PRODUCT ISSUE WAS IDENTIFIED FOR THE CELL-DYN 1800 ANALYZER, FOR ISSUES WITH HEMOGLOBIN OR HEMATOCRIT. NO DEFICIENCY WAS IDENTIFIED. THIS IS THE FINAL REPORT. END OF REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THEY HAVE GENERATED DISCREPANT HEMOGLOBIN RESULTS ON THE CELL-DYN 1800 ANALYZER AFTER SERVICE HAD BEEN IN TO RESOLVE THE ISSUE. A PATIENT GENERATED THE FOLLOWING RESULTS: HEMOGLOBIN (HGB) 8.8 G/DL, HEMATOCRIT (HCT) 28.3% AND RBC OF 2.01 M/UL. THE SAMPLE WAS RETESTED 3 MINUTES LATER YIELDING A HGB OF 11.5 G/DL, HCT OF 36.8% AND RBC OF 3.91 M/UL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD1800 ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELLDYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1