BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 1800 ANALYZER

    MDR report key: 1406981 · Received June 26, 2009

    Report

    Report Number
    2919069-2009-00190
    Event Type
    Malfunction
    Date Received
    June 26, 2009
    Date of Event
    June 10, 2009
    Report Date
    June 10, 2009
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    PMA / PMN Number
    K030513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    INTERNAL IDENTIFIER(S): =056/1-788717274-01 OTHER CODES: 100: CLOGGED S2 TUBING INVESTIGATION SUMMARY: THE CUSTOMER STATED THAT ALL MAINTENANCE WAS UP TO DATE ON THE CELL-DYN 1800 INSTRUMENT. SYRINGES WERE CLEANED AND PROPERLY SEATED WITH NO BUBBLE, SAMPLES WERE MIXED USUALLY FIVE (5) MINUTES ON THE MECHANICAL ROCKER AND INVERTED AGAIN BEFORE ASPIRATION; HOWEVER, THIS HAS BEEN THE PRACTICE FOR A LONG TIME. THE SAMPLE SYRINGE WAS LAST CHANGED IN MARCH 2009. SERVICE WAS PERFORMED ON THE INSTRUMENT IN MARCH 2009 FOR IMPRECISION ISSUES AND THE FIELD SERVICE REPRESENTATIVE (FSR) REPLACED THE S2 TUBING, WHICH RESOLVED THE ISSUE. THE CUSTOMER TECHNICAL ADVOCATE (CTA) INSTRUCTED THE CUSTOMER TO CHECK BUBBLE MIXING IN THE PREMIX CUP AND WBC/RBC MIXING CHAMBER; ALL APPEAR TO BE PROVIDING SUFFICIENT BUBBLE MIXING. HGB REFERENCE VALUE WAS 1881 (SPECIFICATIONS OF 2000 +/- 200). ALL REAGENTS IN USE WERE CORRECT. THE CTA SUGGESTED TO THE CUSTOMER TO EXERCISING VALVES 2-2 (PREMIX CUP BUBBLE MIX), 2-3 (RBC/PLT MIXING CHAMBER BUBBLE MIX), AND 4-7 (WBC MIX CHAMBER BUBBLE MIX), MASSAGE THE PINCHED TUBING, CLEAN THE HGB FLOW CELL AND RUN A PRECISION CHECK WITH FRESH NORMAL BLOOD SAMPLE. THE CTA SUGGESTED A FIELD SERVICE VISIT TO INSPECT THE CELL-DYN 1800. ON (B)(6) 2009, A FIELD SERVICE REPRESENTATIVE PLACED A CALL TO THE CUSTOMER IN ORDER TO TROUBLESHOOT OVER THE PHONE. THE S2 TUBING WAS CLOGGED; THE CUSTOMER PROCEEDED TO PERFORM CLEAN FOR SHIPPING AND VERIFIED BACKGROUND COUNTS AND QUALITY CONTROLS (QC) WERE WITHIN RANGE. THE CELL-DYN 1800 INSTRUMENT WAS WITHIN SPECIFICATIONS AND NO FURTHER INVESTIGATION WAS REQUIRED. ON (B)(4) 2009, THE CTA FOLLOWED-UP WITH THE CUSTOMER THAT STATED THAT QC WAS WITHIN RANGE AND PATIENT RESULTS WERE GOOD AFTER OVER THE PHONE SERVICE WAS PERFORMED ON (B)(6) 2009. THE CUSTOMER REQUIRED NO FURTHER ASSISTANCE. THE ISSUE IS COVERED IN THE PRODUCT LABELING. A NON-STATISTICAL TREND (NST) REVIEW WAS PERFORMED AND NO NST WAS IDENTIFIED. BASED ON THE INVESTIGATION, NO PRODUCT ISSUE WAS IDENTIFIED FOR THE CELL-DYN 1800 RELATED TO THE REPORTED ISSUE. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THE CELL-DYN 1800 GENERATED FALSELY DECREASED HEMOGLOBIN PATIENT RESULTS. A PATIENT SAMPLE GENERATED AN INITIAL HEMOGLOBIN RESULT OF 7.1 G/DL. THE SAMPLE WAS REPEATED AND GENERATED A 10.0 G/DL WHICH WAS REPORTED TO THE PHYSICIAN. THROUGH TROUBLESHOOTING A CLOG WAS CLEARED FROM THE SILICON TUBING. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 1800 ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELLDYN

    Patients

    Seq Age Sex Outcome Treatment
    1 TUBING SILICON