BEUDAMED
    FDA Adverse Event Death Summary report: N

    CELL-DYN RUBY ANALYZER

    MDR report key: 3628689 · Received February 14, 2014

    Report

    Report Number
    2919069-2014-00006
    Event Type
    Death
    Date Received
    February 14, 2014
    Date of Event
    January 20, 2014
    Report Date
    January 21, 2014
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K061667
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE HIGH CONCENTRATION OF LYMPH AND LIPOPROTEINS (FATS) IN THIS SPECIFIC PATIENT SAMPLE AFFECTED THE CELL-DYN RUBY HEMOGLOBIN (HGB) RESULT. FOR SAMPLES WITH HIGH PLASMA CONCENTRATION, IN THIS CASE SEVERE LIPEMIA, THE HGB RESULT OBTAINED FROM THE ANALYZER SHOULD BE VERIFIED BEFORE REPORTING. THE CELL-DYN RUBY SYSTEM OPERATOR'S MANUAL, SECTION 7, PAGE 8, COVERS INTERFERING SUBSTANCES AND CONDITIONS RELATED TO THIS INCIDENT. THE PATIENT SAMPLE WAS NOT AVAILABLE FROM THE CUSTOMER FOR TESTING. BASED ON THE INVESTIGATION PERFORMED, WHICH INCLUDED REVIEW OF THE PRODUCT HISTORICAL DATA, LABELING, AND CONSULTATION WITH THE ABBOTT ASSOCIATE MEDICAL DIRECTOR, A PRODUCT DEFICIENCY FOR THE CELL-DYN RUBY SYSTEM WAS NOT IDENTIFIED. THE COMPLAINT INVOLVES A PATIENT SAMPLE-SPECIFIC RELATED INCIDENT. THE CELL-DYN RUBY INSTRUMENT IS PERFORMING AS DESIGNED WHEN PRESENTED WITH A PATHOLOGICAL SAMPLE, IN THIS CASE, A SEVERE LIPEMIA SAMPLE.

    Description of Event or Problem · 1

    THE CUSTOMER REQUESTED INSTRUCTIONS REGARDING REDUCING INTERFERENCE FOR PATIENT SAMPLES WITH HIGH BILIRUBIN AND LIPID CONTENT WHEN TESTED ON THE CELL-DYN RUBY ANALYZER. THE CUSTOMER STATED THAT A PATIENT SAMPLE WITH A HIGH BILIRUBIN VALUE AND A LARGE QUANTITY OF VISIBLE WHITE LIPID MATERIAL PRODUCED A FALSELY ELEVATED HEMOGLOBIN RESULT OF 17 G/DL ON THE CELL-DYN RUBY ANALYZER. THE RESULT WAS REPORTED OUT OF THE LABORATORY AND QUESTIONED BECAUSE IT DID NOT MATCH THE PATIENT'S HEMOGLOBIN RESULT OF APPROXIMATELY 5 G/DL PER BLOOD GAS ANALYSIS. MULTIPLE PARAMETERS WERE FLAGGED BY THE CELL-DYN RUBY INDICATING THAT RESULTS REQUIRED VERIFICATION. WHILE AN ABBOTT SERVICE REPRESENTATIVE WAS DISCUSSING THE SAMPLE WITH THE CUSTOMER, THE CUSTOMER STATED THAT THE PATIENT HAD DIED. THE CUSTOMER COULD NOT PROVIDE THE PATIENT DIAGNOSIS, DATE OF THE PATIENT DEATH OR CAUSE OF DEATH DUE TO CONFIDENTIALITY. THE CUSTOMER STATED THAT THE PATIENT WAS ELDERLY AND IN VERY POOR HEALTH, AND THAT THE FALSELY ELEVATED CELL-DYN RUBY HEMOGLOBIN RESULT DID NOT CONTRIBUTE TO THE PATIENT'S DEATH. THE CUSTOMER STATED THEY UNDERSTOOD THAT INTERFERENCE IN THE SAMPLE CAUSED THE HEMOGLOBIN RESULT TO BE FALSELY ELEVATED, BUT WANTED TO KNOW IF THERE WAS ANY WAY TO REDUCE THE INTERFERENCE FOR FUTURE SAMPLES SUCH AS THIS. AN ABBOTT SERVICE REPRESENTATIVE VISITED THE ACCOUNT AND CONFIRMED THERE WERE NO ISSUES WITH THE CELL-DYN RUBY ANALYZER. THE ANALYZER WAS FOUND TO BE OPERATING WITHIN SPECIFICATIONS. GUIDANCE WAS PROVIDED TO THE CUSTOMER REGARDING REDUCING INTERFERENCE INCLUDING DILUTING THE SAMPLE AND REMOVING ANY WHITE PARTICULATE MATTER PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98346 CELL-DYN RUBY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 Death