BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 3000 SL ANALYZER

    MDR report key: 1241424 · Received November 25, 2008

    Report

    Report Number
    2919069-2008-00792
    Event Type
    Malfunction
    Date Received
    November 25, 2008
    Date of Event
    November 5, 2008
    Report Date
    November 5, 2008
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    PMA / PMN Number
    K980614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: POOR MIXING PADDLE POSITION/INSUFFICIENT SAMPLE VOLUME; INSUFFICIENT SAMPLE VOLUME. IN RESPONSE TO THIS ISSUE AN INVESTIGATION WAS INITIATED TO FURTHER EXAMINE THE CUSTOMER ISSUE. THE INVESTIGATION INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS AND A REVIEW OF LABELING. THE CUSTOMER INDICATED DISCREPANT RESULTS WERE GENERATED BETWEEN OPEN AND CLOSED MODES WITH THE CELL-DYN 3000 INSTRUMENT AND REQUESTED REPLACEMENT OF THE CLOSED MODE NEEDLE. A FIELD SERVICE ENGINEER (FSE) SERVICED THE INSTRUMENT. INSTRUMENT DATA INDICATED LOW VALUES WERE GENERATED IN CLOSED MODE TESTING. THE PATIENT SAMPLE IN QUESTION HAD LATHERED ABNORMALLY AFTER MIXING DUE TO A POOR MIXING PADDLE POSITION. THE PATIENT SAMPLE DID NOT CONTAIN ADEQUATE SPECIMEN QUANTITY; THE POOR MIXING DECREASED THE LIQUID SURFACE RESULTING IN ASPIRATED BUBBLES. THE FSE ADJUSTED THE MIXING PADDLE POSITION AND CONFIRMED NORMAL MOVEMENT OF THE MIXING PADDLE BY MANUAL MODE. ADDITIONALLY, THE FSE CHECKED REPRODUCIBILITY, CONFIRMED THE INSTRUMENT WAS PERFORMING CORRECTLY IN THE CLOSED MODE TEST, AND VERIFIED THE INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS. THE CELL-DYN 3000 SYSTEM OPERATOR'S MANUAL (LIST NUMBER 92420-01, REVISION H) UNDER SECTION 10, TROUBLESHOOTING, PAGE 10-1, PROVIDES INSTRUCTIONS FOR IDENTIFYING, TROUBLESHOOTING, AND CORRECTING INSTRUMENT PROBLEMS. INSTRUCTIONS ARE ALSO PROVIDED FOR OBTAINING TECHNICAL ASSISTANCE FROM ABBOTT DIAGNOSTICS CUSTOMER SERVICE. ADDITIONALLY, CHAPTER 4, SYSTEM SPECIFICATION, SAMPLE VOLUME, PAGE 4-4, INDICATES THAT THE MINIMUM SAMPLE VOLUME IS 1 ML, WITH A MAXIMUM OF 3 ML. THE SAMPLE VOLUME IN THE TUBE MUST BE WITHIN THE SPECIFIED LIMITS FOR ADEQUATE MIXING AND SAMPLING. A REVIEW OF THE COMPLAINT TRENDING SYSTEMS, FOR THE PERIOD (B)(6) 2007 THROUGH (B)(6) 2008, DID NOT INDICATE ANY ADVERSE TREND FOR THE CELL-DYN 3000, LIST 91325-01 FOR REPORTED ISSUE. BASED ON THE INVESTIGATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE CELL-DYN 3000 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 COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT ONE PATIENT SAMPLE GENERATED DISCREPANT RESULTS WHEN ANALYZED IN AN OPEN, AND THE CLOSED MODE OF OPERATION ON THE CELL-DYN 3000SL ANALYZER. SEE DATA BELOW. CLOSED MODE OPEN MODEWBC (K/UL) 4.5 17.3RBC (M/UL) 3.11 5.16HGB (G/DL) 9.1 16.2HCT (%) 30.2 49.5PLTS (K/UL) 193 397A SERVICE CALL WAS INITIATED. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 3000 SL ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELLDYN

    Patients

    Seq Age Sex Outcome Treatment
    1