BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 1800 ANALYZER

    MDR report key: 1268897 · Received December 23, 2008

    Report

    Report Number
    2919069-2008-00830
    Event Type
    Malfunction
    Date Received
    December 23, 2008
    Date of Event
    December 11, 2008
    Report Date
    December 10, 2008
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    PMA / PMN Number
    K030513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: AFTER REVIEWING THE DATA SENT BY THE CUSTOMER, THE CTA SUGGESTED A SMEAR REVIEW OF THE PATIENT SAMPLE FOR RBC MORPHOLOGY AND ROULEAU/CLUMPS. THE CUSTOMER STATED NOT HAVING TIME FOR A SMEAR REVIEW AND THAT THE SAMPLE WAS GOING TO BE SENT TO A REFERENCE LABORATORY. THE CUSTOMER THEN REQUESTED FIELD SERVICE FOR ISSUE RESOLUTION. ON (B)(6) 2008, THE FIELD SERVICE REPRESENTATIVE (FSR) CLEANED AN OBSTRUCTED SILICON TUBING (S1), RAN CONTROLS, AND PASSED. THE INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS. ON (B)(6) 2008, DURING AN FSR VISIT, A PRINTED CIRCUIT BOARD ASSEMBLY WAS REPLACED ON THE INSTRUMENT, RAN CONTROLS, AND QC PASSED. INSTRUMENT WAS PERFORMING PER SPECIFICATIONS AND NO FURTHER INVESTIGATION WAS REQUIRED. THE ISSUE IS ADDRESSED IN LABELING IN THE CELL-DYN 1800 SYSTEM OPERATOR'S MANUAL. A REVIEW OF COMPLAINT) REPORTS DID NOT INDICATE ANY ADVERSE TREND FOR THE CELL-DYN 1800, L/N 07H77-01, FOR THE REPORTED COMPLAINT ISSUE. BASED ON THE INVESTIGATION, NO PRODUCT ISSUE WAS IDENTIFIED FOR THE CELL-DYN 1800 FOR THE REPORTED ISSUE. THERE WAS NO SYSTEMIC ISSUE FOR THE CELL-DYN 1800 PRODUCT LINE. 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 STATES THAT HEMOGLOBIN (HGB) AND HEMATOCRIT (HCT) VALUES ARE NOT MATCHING THE RULE OF 3 WELL FOR PATIENT SAMPLES TESTED USING A CELL-DYN 1800 ANALYZER. IN 2008, ONE PATIENT SAMPLE GENERATED A HGB=11.9 G/DL AND HCT=34.2%. THE SAMPLE WAS REPEATED THE SAME DAY YIELDING HGB=7.8 G/DL AND HCT=21.9%. THE NEXT DAY, THE SAMPLE WAS REPEATED 10 TIMES YIELDING HEMOGLOBIN VALUES RANGING FROM 12.2 TO 12.4 G/DL AND HEMATOCRIT VALUES RANGED FROM 35.3 TO 36.7%. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED DUE TO THIS ISSUE.

    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 81 YR