BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 1800 ANALYZER

    MDR report key: 2063245 · Received April 19, 2011

    Report

    Report Number
    2919069-2011-00169
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 25, 2011
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K030513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER AND THE CUSTOMER TECHNICAL ADVOCATE CONCLUDED THAT THE MOST LIKELY CAUSE OF THE DISCREPANT RESULT WAS DUE TO SAMPLE INTEGRITY, WHICH WAS RESOLVED AFTER REDRAWING A NEW SAMPLE. A TOTAL OF FOUR (5) PAGES OF DATA WERE SUBMITTED TO AID WITH THE INVESTIGATION, WHICH INCLUDED FOUR (4) PAGES AND ONE (1) PATIENT OF PRECISION RESULT. THE DATA CONFIRMED THE CUSTOMER'S CONCERN OF LOW HGB, RBC, AND HCT RESULTS ON THE THREE (3) SAMPLES RAN ON THE CELL-DYN 1800 INSTRUMENTS. THE DATA SHOWED THAT ALL THREE (3) SAMPLES HAD UNDERLINED HGB, RBC, AND HCT RESULTS WITH "L" AND "LL" FLAGS, WHICH INDICATED RESULTS OUTSIDE OPERATOR-ENTERED LIMITS. THE DATA DEMONSTRATED LOW PLT RESULTS ON ALL THREE (3) RUNS AND LOW WBC RESULTS IN ONE (1) OUT OF THE THREE (1) RUNS. THE CELL-DYN 1800 SYSTEM OPERATOR'S MANUAL, TROUBLESHOOTING AND DIAGNOSTICS SECTION STATES THAT IF THE RESULTS EXCEED THE OPERATOR-ENTERED LIMIT FOR WBC, RBC, HGB, OR PLT, FOLLOW ESTABLISHED LABORATORY OPERATING PROCEDURES. OTHER CORRECTIVE ACTIONS INCLUDE CONFIRMING BACKGROUND DATA, RE-RUNNING SPECIMEN AND IF APPROPRIATE, VIEW STAINED SMEAR TO RECONFIRM COUNT. THE CELL-DYN 1800 SYSTEM OPERATOR'S MANUAL, PRINCIPLES OF OPERATION, SUBSECTION: DISPERSIONAL DATA ALERTS, STATES THAT IF RESULTS FOR A PARAMETER FALL BETWEEN THE LOWER PATIENT LIMIT AND THE LOWER PANIC LIMIT, THE RESULTS ARE HIGHLIGHTED (WHITE LETTERING ON BLUE BACKGROUND) ON THE SCREEN. ON THE PRINTOUT, THE RESULTS ARE UNDERLINED AND THE LETTER "L" IS PRINTED IN THE FLAG FIELD. IF RESULTS FOR A PARAMETER FALL BETWEEN THE LOWER PANIC LIMIT AND THE LOWER PRINTED REPORT RANGE LIMIT, THE RESULTS ARE HIGHLIGHTED (WHITE LETTERING ON RED BACKGROUND) ON THE SCREEN, AND THE LETTERS "LL" ARE PRINTED IN THE FLAG FIELD ON THE PRINTOUT. WHEN A RESULT IS FLAGGED WITH A LIMITS ALERT, IT IS RECOMMENDED THAT THE ACCOUNT FOLLOW THEIR LABORATORY'S REVIEW CRITERIA, WHICH MAY INCLUDE REVIEW OF A STAINED SMEAR TO VERIFY THE RESULT AND TO CHECK FOR THE PRESENCE OF ANY ADDITIONAL ABNORMALITY. A NON-STATISTICAL TREND (NST) REVIEW WAS PERFORMED IN THE COMPLAINT ANALYSIS TRENDING SYSTEM FOR THE REPORTED ISSUE FROM (B)(4) 2011 THROUGH (B)(4) 2011. NO NST WAS IDENTIFIED DURING THE SEARCHED PERIOD. BASED ON THE INVESTIGATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE CELL-DYN 1800 RELATED TO THE REPORTED ISSUE.

    Additional Manufacturer Narrative · 1

    (B)(4). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. AN INVESTIGATION IS IN PROCESS.

    Description of Event or Problem · 1

    THE ACCOUNT GENERATED CELL-DYN 1800 DEPRESSED HEMOGLOBIN, RBC AND HEMATOCRIT RESULTS ON A CHILD PATIENT WHO HAD A HISTORY OF LOW IRON. THE MICROTAINER SAMPLE WAS PROCESSED SEVERAL TIMES ON THE CELL-DYN 1800 WITH INCONSISTENT LOW RESULTS. A VENOUS SPECIMEN WAS OBTAINED FROM THE PATIENT AND SENT TO A REFERENCE LABORATORY WITH NORMAL CBC RESULTS. THE PATIENT WAS UNNECESSARILY TREATED WITH VITAMINS AND IRON SUPPLEMENTS BASED ON THE DEPRESSED CELL-DYN 1800 RESULTS. NO ADDITIONAL IMPACT TO PATIENT MANAGEMENT WAS REPORTED. SAMPLE INTEGRITY OF THE MICROTAINER SPECIMEN WAS QUESTIONED. DATA PROVIDED: CELL-DYN 1800, MICROTAINER SPECIMEN, RBC = 3.20, 2.07, 3.19 M/UL, HGB = 9.6, 5.9, 9.6 G/DL, HCT = 28.4, 18.1, 28.4 %. UNKNOWN METHOD: VENOUS SPECIMEN, RBC = 4.30 X10E6/UL, HGB = 12.9 G/DL, HCT = 37.2 %.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Other