BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN RUBY ANALYZER

    MDR report key: 4152764 · Received October 8, 2014

    Report

    Report Number
    2919069-2014-00064
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 18, 2014
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K061667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO CUSTOMER RETURN SAMPLE WAS AVAILABLE FOR EVALUATION. A REVIEW OF THE COMPLAINT INFORMATION AND SUBMITTED DATA WAS PERFORMED. THE SPECIFIC PATIENT SAMPLE HAD INTERFERING SUBSTANCES AND CONDITION, IN THIS CASE SCHISTOCYTES. SCHISTOCYTES COULD BE THE INTERFERING SUBSTANCE FOR RED BLOOD CELL/ PLATELET (RBC/PLT) ALGORITHM RESULTING IN SCHISTOCYTES BEING MISTAKENLY IDENTIFIED AS PLT OR UNDERCOUNTING PLT BY ELIMINATING EVENTS CONTAINING SCHISTOCYTES. THIS EVENT IS COVERED IN THE CELL-DYN RUBY SYSTEM OPERATOR'S MANUAL, UNDER INTERFERING SUBSTANCES AND CONDITIONS. BASED ON THE EVALUATION WHICH INCLUDED REVIEW OF PRODUCT HISTORICAL DATA, AND PRODUCT LABELING, IT WAS CONCLUDED THAT THE EVENT WAS SAMPLE-SPECIFIC AND WAS AN ISOLATED INCIDENT. A PRODUCT ISSUE WAS NOT DETERMINED FOR THE CELL-DYN RUBY SYSTEM.

    Additional Manufacturer Narrative · 1

    CORRECTED FACILITY NAME AND ADDRESS. AN EVALUATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE ACCOUNT GENERATED A FALSELY DEPRESSED PLATELET (PLT) OF 1.87 10E4/UL ON THE CELL-DYN RUBY WITH SAMPLE ID (B)(6). THE SAMPLE WAS REPEATED WITH PLT OF 4.78 10E4/UL AND SHOWED A SMEAR PLT ESTIMATE OF 50,000/UL. THE PLT ESTIMATE OF 50,000/UL WAS REPORTED OUTSIDE THE LABORATORY. NO SPECIFIC PATIENT INFORMATION IS AVAILABLE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631230 CELL-DYN RUBY ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1