BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD1800 ANALYZER

    MDR report key: 1038413 · Received May 6, 2008

    Report

    Report Number
    2919069-2008-00536
    Event Type
    Malfunction
    Date Received
    May 6, 2008
    Date of Event
    April 9, 2008
    Report Date
    April 10, 2008
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELL DYN
    Product Code
    GKZ
    PMA / PMN Number
    K030513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (LYSE TUBING IN NCV58). THE CELL-DYN 1800 INSTRUMENT GENERATED DISCREPANT HEMOGLOBIN RESULTS FOR A PATIENT SAMPLE. THERE WAS NO IMPACT TO PATIENT RESULTS AS THE CUSTOMER REVIEWED A SMEAR PRIOR TO RELEASE OF RESULTS. QC WAS WITHIN RANGE. THE CUSTOMER RAN PRECISION AND THE PRECISION FOR HGB WAS 1.6* (<=1.2) WHICH IS OUT OF RANGE. WHILE TROUBLESHOOTING WITH THE CUSTOMER TECHNICAL ADVOCATE (CTA), THE CUSTOMER VERIFIED THAT THE LYSE TUBING WAS NOT SEALED PROPERLY IN NCV 58 (NORMALLY CLOSED VALVE 58). CTA HAD CUSTOMER MASSAGE AND RESET TUBING, PRIME, REPEAT BACKGROUND, REPEAT MULTIPLE SAMPLES MULTIPLE TIMES. RESULTS WERE MATCHING WITH PREVIOUS RESULTS AND MATCHED WITH RESULTS FROM REPEAT RUNS. ON FOLLOW-UP (2008) THE CUSTOMER REPORTED THE INSTRUMENT WAS OPERATING PER LABELING. NO FURTHER ASSISTANCE WAS REQUIRED. A REVIEW OF THE COMPLAINTS FOR THE PERIOD 2007 THROUGH 2008, DID NOT INDICATE ANY ADVERSE TREND WITH THE CELL-DYN 1800, LIST BASE 07H77-01 FOR THIS ISSUE. THERE WAS NO SYSTEMIC ISSUE. THE CELL-DYN SYSTEM 1800 OPERATOR'S MANUAL, 07H80-01, REV D: SECTION 9: UNDER DAILY START-UP PROCEDURE THE FOURTH ITEM ON THE CHECKLIST IS TO CHECK TUBING IN THE NORMALLY CLOSED VALVES FOR CRIMPS (9-15). SECTION 10: A TROUBLESHOOTING GUIDE IS PROVIDED ON PAGE (10-36), UNDER DATA PROBLEMS (INACCURATE WBC/HGB READINGS DUE TO INCORRECT/INCONSISTENT INJECTION OF LYSE) ONE PROBABLE CAUSE IS IMPROPER DELIVERY OF LYSE REAGENT. THIS IS A FINAL REPORT. END OF REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THE CELL-DYN 1800 ANALYZER GENERATED DISCREPANT HEMOGLOBIN RESULTS FOR A PATIENT. THE INSTRUMENT GENERATED HEMOGLOBIN RESULT OF 8.2 G/DL. UPON REPEAT, THE HEMOGLOBIN RESULT WAS 12.0 G/DL. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD1800 ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELL DYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI