BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN WBC REAGENT A

    MDR report key: 1052981 · Received May 27, 2008

    Report

    Report Number
    2919069-2008-00553
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    May 9, 2008
    Report Date
    May 9, 2008
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    PMA / PMN Number
    K051215
    Removal / Correction Number
    Z-1103-2008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ANALYZER SERIAL# (B)(4). EVALUATION, METHOD: MICROBIAL TESTING OF OPENED/UNOPENED REAGENTS AND RETENTION LOTS. EVALUATION, RESULTS: WBC REAGENT PART A (LIST 01H77-01, LOTS 51749I2, 51754I2, AND 56675I2). THERE IS NO 510(K) NUMBER FOR CELL-DYN WBC REAGENT A. THE 510(K) FILED WITH THE INITIAL MDR REFLECTS THE CELL-DYN SAPPHIRE. THE CELL-DYN 4000 AND CELL-DYN SAPPHIRE ANALYZERS WERE EXPERIENCING ELEVATED WBC BACKGROUND COUNTS IN THE FIELD. BACKGROUND COUNTS WERE RECOVERING UP TO 0.5 X 103/UL. THE SPECIFICATION FOR WBC BACKGROUND READINGS IS LESS THAN OR EQUAL TO 0.10X103/UL PER THE CELL-DYN SAPPHIRE OPERATOR'S MANUAL, LIST NUMBER 08H10-01, REVISION D AND CELL-DYN 4000 SYSTEM OPERATOR'S MANUAL, LIST NUMBER 01H25-01, REVISION M. BACKGROUNDS COUNTS MUST BE WITHIN SPECIFICATION PRIOR TO REPORTING OF PATIENT SAMPLES. IF THE OPERATOR PROCEEDS TO RUN PATIENT SAMPLES WITH BACKGROUND COUNTS OUT OF SPECIFICATION, RESULTS MAY EXHIBIT FLUORESCENT PARTICLE FLAGGING, FLUORESCENT CHANNEL 3 FLAGS, RESISTANT RBC FLAGS, INCREASED NUCLEATED RBC FLAGS OR ABNORMAL WBC HISTOGRAM SCATTER PLOTS. IF PRODUCT LABELING IS NOT FOLLOWED AND PATIENT RESULTS ARE REPORTED, WBC RESULTS MAY BE INACCURATE AND HIGHER THAN ACTUAL RESULTS; HOWEVER, IT IS UNLIKELY THAT PATIENT MANAGEMENT WOULD BE ADVERSELY AFFECTED. INVESTIGATION ON THIS ISSUE DETECTED MICROBIAL CONTAMINATION IN THE WBC REAGENT PART A, LIST NUMBER 01H77-01, WHICH IS DISTRIBUTED FOR USE WITH THE CELL-DYN SAPPHIRE AND CELL-DYN 4000 INSTRUMENTS. THE MICROBIAL CONTAMINATION WAS IDENTIFIED ONLY ON LOTS 51749I2, 51754I2, AND 56675I2 OF WBC REAGENT PART A, LIST NUMBER 01H77-01. THE CONTAMINANT HAS BEEN IDENTIFIED TO BE PSEUDOMONAS SPECIES, AN ENVIRONMENTAL ISOLATE COMMON IN BIO-FILMS, AND DOES NOT PRESENT A SAFETY HAZARD. THE MICROBIAL CONTAMINATION, SPORADIC IN NATURE, CAN AFFECT OTHER LOTS OF WBC REAGENT PART A, AS MICROBIAL CONTAMINATION WITHIN THE WBC REAGENT PART A CAN FURTHER CONTAMINATE THE CELL-DYN SAPPHIRE AND CELL-DYN 4000 SYSTEMS. THE SOURCE OF THE MICROBIAL CONTAMINATION WAS DETERMINED TO BE CAUSED BY A COMBINATION OF FACTORS, INCLUDING LACK OF FILTRATION OF WATER USED FOR CLEANING PROCEDURES, BIOFILM SHEDDING IN THE FILL LINE, INCREASED BIOBURDEN DUE TO STAGNANT ZONES IN THE FILL-LINE AREA AND FAILURE TO ACCURATELY DETECT CONTAMINATION AS PART OF PRODUCT RELEASE. THE FOLLOWING CORRECTIVE ACTIONS WERE PUT IN PLACE IN ORDER TO ADDRESS THE MICROBIAL CONTAMINATION: ALL THREE AFFECTED LOTS WERE RECALLED FROM THE FIELD AND CUSTOMERS WERE INSTRUCTED TO DECONTAMINATE THEIR INSTRUMENTS PRIOR TO USING ANY NEW WBC REAGENT PART A. INCORPORATION OF AN IMPROVED MICROBIAL TESTING METHOD INTO THE CURRENT PROCESS. INCREASED FREQUENCY OF SANITIZATION IN THE FILL-LINE AREA, INCLUDING FILTRATION OF THE WATER USED FOR CLEANING-IN-PLACE PROCEDURES. INCREASED FLUSHING OF THE FILL-LINE EQUIPMENT AND AUTOCLAVING OF FILL-LINE COMPONENTS, SUCH AS NOZZLES. COMPLETION OF THE FINAL CORRECTIVE ACTIONS HAS BEEN TARGETED FOR THE END OF 4TH QUARTER 2008. BASED ON THE INVESTIGATION FINDINGS, THE MICROBIAL CONTAMINATION HAS BEEN IDENTIFIED ONLY IN WBC PART A REAGENT, LIST NUMBER 01H77-01, FOR LOTS 51749I2, 51754I2 AND 56675I2; HOWEVER, IF THE INSTRUMENT IS NOT PROPERLY DECONTAMINATED, THE CONTAMINATED WBC REAGENT PART A HAS THE POTENTIAL TO SPREAD TO THE CELL-DYN SAPPHIRE AND CELL-DYN 4000 INSTRUMENTS AND CAN THEN BACK-CONTAMINATE OTHER BOTTLES OF WBC REAGENT PART A PLACED ON THE CONTAMINATED INSTRUMENT. THIS IS THE FINAL REPORT.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THERE WERE ELEVATED WHITE BLOOD CELL (WBC) VALUES ON THE CELL-DYN SAPPHIRE ANALYZER WHILE USING THE WBC REAGENT A, LOT 60275I2 AND 60276I2. AFTER DECONTAMINATING AND INSTALLING A NEW WBC REAGENT A, THE WBC ZERO VALUES RETURNED TO ZERO. NO OTHER LOT OF WBC REAGENT A WAS AVAILABLE. NO IMPACT TO PT MGMT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN WBC REAGENT A WBC REAGENT A FOR USE ON THE CELL-DYN ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELLDYN NA 60275I2

    Patients

    Seq Age Sex Outcome Treatment
    1 NI SERIAL# (B)(4)| CELL-DYN SAPPHIRE ANALYZER, LIST# 8H00-01| CELL-DYN SAPPHIRE ANALYZER, LIST# 8H00-01