BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN RUBY ANALYZER

    MDR report key: 3971770 · Received July 31, 2014

    Report

    Report Number
    2919069-2014-00045
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 7, 2014
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K061667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE POSSIBILITY THAT THE FIRST DRAWN SAMPLE AT THE HOSPITAL WAS IMPROPERLY MIXED BEFORE BEING RUN ON THE CELL-DYN RUBY WAS DISCUSSED WITH THE CUSTOMER. ABBOTT FIELD SERVICE WAS REQUESTED TO MAKE SURE THE INSTRUMENT WAS WORKING AS EXPECTED. INSTRUMENT PERFORMANCE PER LABELING WAS VERIFIED. THE CUSTOMER PERFORMED PRECISION TESTING WHICH WAS WITHIN SPECIFICATION FOR HEMOGLOBIN. NO OTHER INCIDENTS WERE NOTED. A REVIEW OF LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. NO DEFICIENCY WAS IDENTIFIED FOR THE CELL-DYN RUBY ANALYZER.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT A CELL-DYN RUBY HEMOGLOBIN RESULT OF 7.41 G/DL WAS GENERATED FOR A MALE PATIENT (ID (B)(6)) ON (B)(6) 2014, AT 9:40 A.M. THE PATIENT WAS REDRAWN FOR TRANSFUSION THE SAME DAY AT 6:35 P.M. AND THE CELL-DYN RUBY HEMOGLOBIN RESULT WAS 15.1 G/DL. THE REDRAW SAMPLE WAS RETESTED BECAUSE THE RESULTS DID NOT MATCH. THE RETEST RESULTS WERE 8.11 AND 8.06 G/DL. THE PATIENT RECEIVED THE BLOOD TRANSFUSION BASED ON THE REPRODUCIBLE LOW HEMOGLOBIN RESULTS WHICH MATCHED THE PATIENT'S CLINICAL DIAGNOSIS. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449142 CELL-DYN RUBY ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR