BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN RUBY ANALYZER

    MDR report key: 7778557 · Received August 13, 2018

    Report

    Report Number
    2919069-2018-00040
    Event Type
    Malfunction
    Date Received
    August 13, 2018
    Date of Event
    July 23, 2018
    Report Date
    September 10, 2018
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    UDI-DI
    00380740017170
    PMA / PMN Number
    K061667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF PRODUCT HISTORICAL DATA DID NOT IDENTIFY ANY TRENDS OR SIMILAR COMPLAINTS FOR THE CUSTOMER'S ISSUE. THE ANALYTICAL MEASUREMENT RANGE (AMR) FOR THE CELL-DYN RUBY ANALYZER FOR WBC IS 0.0 TO 246.8. THE INITIAL CHRONIC MYELOID LEUKEMIA PATIENT'S WBC RESULT (SID002) ON THE CELL DYN RUBY WAS 288, WHICH WAS ABOVE THE ANALYZER'S AMR. THE DILUTED SAMPLE GENERATED WBC OF 135 10E3/UL AND IF MULTIPLIED BY 2, WOULD RESULT IN 270, ALSO ABOVE THE AMR. THE SID002 GENERATED A LOW PLT RESULT OF 1.37 10E3/UL FROM THE CELL DYN RUBY WHICH MAY HAVE BEEN DUE TO THE LOW MCV RESULT OF 72.0FL. DURING THE IMPEDANCE COUNTING IN THE REFERENCE INSTRUMENT (MINDRAY), THE LOW MCV MAY BE CAUSING AN ISSUE IN SEPARATING THE SMALL RBC AND THE LARGE PLT RESULTING IN AN OVERESTIMATED PLT COUNT. THE HEMOGLOBIN DISCREPANCY WITH SID056 COULD POSSIBLY BE DUE TO A COMPROMISED SAMPLE RELATED TO AN IN-VITRO HEMOLYSIS. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE, THEREFORE THE CAUSE COULD NOT BE ELIMINATED FOR SID056. BOTH ISSUES APPEAR TO BE SAMPLE RELATED. A REVIEW OF LABELING WAS FOUND TO ADEQUATELY ADDRESS THE ISSUE FOR DISPERSIONAL DATA ALERTS; OPERATIONAL MESSAGES AND DATA FLAGGING; AND OPERATIONAL PRECAUTIONS AND LIMITATIONS RELATED TO THESE INCIDENTS. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE CELL DYN RUBY ANALYZER, LIST 08H67-01, SERIAL NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THERE IS NO FURTHER PATIENT INFORMATION PROVIDED BY THE CUSTOMER. (B)(6). SEX = (B)(6) =FEMALE AND (B)(6) = MALE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSELY DECREASED PLATELET (PLT) READING ON A KNOWN CML PATIENT ((B)(6)) ON THE CELL DYN RUBY ANALYZER. THE RESULTS PROVIDED WERE: RUBY PLT = 1.37 / MINDRAY'S IMPEDENCE COUNTER = 70K WHICH CLOSER MATCHES THE MANUAL COUNT. THE CUSTOMER ALSO REPORTED ON A DIFFERENT PATIENT ((B)(6)) A HEMOGLOBIN RESULT OF 5.86G/DL FROM THE RUBY / DIFFERENT SITE SAME DAY = 9.6G/DL. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617475 CELL-DYN RUBY ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION 00380740017170

    Patients

    Seq Age Sex Outcome Treatment
    1