BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN RUBY ANALYZER

    MDR report key: 2873687 · Received December 14, 2012

    Report

    Report Number
    2919069-2012-00081
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 16, 2012
    Report Date
    November 19, 2012
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K061667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN EVALUATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION WAS BASED ON THE CUSTOMER DATA RECEIVED, HISTORICAL DATA REVIEW, AND LABELING REVIEW. NO CUSTOMER RETURNED SPECIMENS WERE AVAILABLE FOR EVALUATION. A REVIEW OF HISTORICAL DATA DID NOT FIND AN ISSUE SIMILAR TO THE CUSTOMER CONCERN. THE FIRST SPECIMEN WAS RUN IN CLOSED MODE WITH A CELL-DYN RUBY, SERIAL NUMBER (B)(4). THE DATA SHOWED THAT THE FIRST SPECIMEN HAD LOW RESULTS ACROSS ALL PARAMETERS, INDICATING THAT THERE MAY NOT HAVE BEEN SUFFICIENT SAMPLE IN THE TUBE FOR THE INSTRUMENT TO ASPIRATE IN CLOSED MODE. THE SECOND SPECIMEN WAS RUN IN OPEN MODE ON A SECOND CELL-DYN RUBY INSTRUMENT. THE SECOND SPECIMEN HAD MUCH HIGHER RESULTS ACROSS ALL PARAMETERS. IT IS POSSIBLE THAT THE TUBE CONTAINED ENOUGH SAMPLE FOR THE INSTRUMENT TO ASPIRATE IN OPEN MODE. IT SHOULD BE NOTED THAT THE CUSTOMER DID NOT REPEAT THE RUN FOR THE SAMPLE IN QUESTION WITH THE SAME INSTRUMENT. THE RUN WAS REPEATED WITH A DIFFERENT INSTRUMENT. IDEALLY, THE SAMPLE SHOULD HAVE BEEN REPEATED WITH THE SAME INSTRUMENT IN ORDER TO RULE OUT AN INSTRUMENT PERFORMANCE, AS IT IS KNOWN THAT CALIBRATION AND OPTIMAL PERFORMANCE VARIES BY INSTRUMENT. THE CELL-DYN RUBY SYSTEM OPERATOR'S MANUAL STATES THAT IN THE CLOSED MODE, THE SPECIMEN VOLUME IS AT LEAST 1.2 ML IN STANDARD COLLECTION TUBES. IN OPEN MODE, THE SPECIMEN VOLUME IS AT LEAST 0.5 ML (500UL) IN STANDARD COLLECTION TUBES, AND 0.18 ML (180UL) IN MICRO-COLLECTION TUBES. NO MALFUNCTION WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE ACCOUNT GENERATED A FALSELY DEPRESSED HEMOGLOBIN OF 5.41 G/DL ON SPECIMEN ID (B)(6) WHEN PROCESSING ON THE CELL-DYN RUBY. ALL CBC PARAMETERS WERE ALSO FALSELY DEPRESSED WITH NO INSTRUMENT ERRORS. THE SAMPLE WAS REPEATED WITH AN EXPECTED HEMOGLOBIN OF 10.9 G/DL. THE FALSELY DEPRESSED HEMOGLOBIN OF 5.41 G/DL WAS NOT REPORTED OUTSIDE OF THE LAB. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR