BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELL-DYN 3200 SL 110V ANALYZER

    MDR report key: 1618017 · Received March 1, 2010

    Report

    Report Number
    2919069-2010-00048
    Event Type
    Injury
    Date Received
    March 1, 2010
    Date of Event
    February 4, 2010
    Report Date
    February 9, 2010
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    PMA / PMN Number
    K972354
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE PATIENT DATA SUBMITTED SHOWED THAT CHEVRONS (>>>> OR <<<<) INSTEAD OF NUMERICAL VALUES FOR WBC, HGB AND PLT PARAMETERS WERE GENERATED AND/OR SUSPECT POPULATION FLAGS. IN ADDITION, THE 1:10 DILUTED SAMPLE RESULTS ALSO CONTAINED A SAMPLING ERROR MESSAGE, INDICATIVE OF INSUFFICIENT SAMPLE DETECTION. THE CELL-DYN 3200 SYSTEM OPERATOR'S MANUAL CONTAINS INFORMATION REGARDING RESULTS THAT EXCEED LINEARITY LIMITS (>>>>), HEMOGLOBIN RESULTS OF (<<<<), SUSPECT PARAMETER FLAGS AND SAMPLING ERRORS. THE CUSTOMER DID NOT PERFORM A SMEAR REVIEW, AS RECOMMENDED PER OPERATION MANUAL INSTRUCTIONS, FOR THE SUSPECT PARAMETER FLAGS GENERATED. A REVIEW OF COMPLAINT RECORDS DID NOT IDENTIFY A PRODUCT ISSUE RELATED TO THE CUSTOMER'S OBSERVATION. A NON-STATISTICAL TREND (NST) REVIEW WAS PERFORMED FOR THE REPORTED ISSUE FROM (B)(4) 2009 THROUGH (B)(4) 2010 AND NO NST WAS IDENTIFIED. BASED ON THE INVESTIGATION, NO PRODUCT ISSUE WAS IDENTIFIED FOR THE CELL-DYN 3200 RELATED TO THE REPORTED ISSUE. THE CELL-DYN 3200 INSTRUMENT FUNCTIONED AS INTENDED, ALERTING THE OPERATOR ON ALL RUNS TO FURTHER VALIDATE RESULTS, AS INDICATED BY THE SUSPECT POPULATION FLAGS. THE CUSTOMER WAS REFERRED TO THE APPROPRIATE SECTIONS OF THE CELL-DYN 3200 OPERATOR'S MANUAL REGARDING FLAGGED RESULTS AND SAMPLING ERRORS.

    Description of Event or Problem · 1

    THE CUSTOMER STATED AN ONCOLOGY PATIENT GENERATED A FALSELY LOW HEMOGLOBIN RESULT ON THE CELL-DYN 3200 ANALYZER AND RECEIVED BLOOD TRANSFUSIONS. THE PATIENT ORIGINALLY GENERATED A WBC OF ">>>>" (LINEARITY EXCEEDED) AND A HEMOGLOBIN RESULT OF "<<<<" (INDICATES POSSIBLE INTERFERENCE WITH HEMOGLOBIN DUE TO ELEVATED WBC). THE SAMPLE WAS DILUTED 1:10 YIELDING A WBC OF 459 K/UL AND A HEMOGLOBIN OF 4.29 G/DL. THE DILUTED RESULTS WERE REPORTED AND THE PATIENT RECEIVED THREE BLOOD TRANSFUSIONS. ANOTHER SAMPLE OBTAINED POST TRANSFUSIONS YIELDED A WBC RESULT OF ">>>>" AND HEMOGLOBIN OF "<<<<." THE POST TRANSFUSION SAMPLE WAS TESTED ON A CELL-DYN 1800 ANALYZER WITH A HEMOGLOBIN RESULT OF 14.3 G/DL. THERE WAS NO ADVERSE IMPACT TO THE PATIENT DUE TO THE TRANSFUSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 3200 SL 110V ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELLDYN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other