BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN RUBY ANALYZER

    MDR report key: 5959431 · Received September 19, 2016

    Report

    Report Number
    2919069-2016-02126
    Event Type
    Malfunction
    Date Received
    September 19, 2016
    Date of Event
    August 16, 2016
    Report Date
    September 19, 2016
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    UDI-DI
    00380740017170
    PMA / PMN Number
    K061667
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. RETURN PARTS WERE NOT AVAILABLE. TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE INVESTIGATION, THE CELL-DYN RUBY SOFTWARE ALGORITHM IS PERFORMING AS DESIGNED WHEN PRESENTED WITH SAMPLES CONTAINING INTERFERING SUBSTANCES AND CONDITIONS, IN THIS CASE, GIANT PLATELETS. THEREFORE, THIS COMPLAINT WAS DUE TO A SAMPLE SPECIFIC INCIDENT. BASED ON THE AVAILABLE INFORMATION NO PRODUCT DEFICIENCY OF THE CELL-DYN RUBY ANALYZER, LIST NUMBER 08H67 WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER INDICATED THAT FALSELY DECREASED PLATELET RESULTS WERE GENERATED WHILE USING THE CELL-DYN RUBY ANALYZER WHICH RESULTED IN AN UNNECESSARY PLATELET TRANSFUSION. THE CUSTOMER PROVIDED THE FOLLOWING RESULTS (10X9/L): ON (B)(6) 2016 (22:05) (B)(6): 1.53. ON (B)(6) 2016 (22:22) (CONFIRMATION TESTING ON ANOTHER RUBY ANALYZER DOCUMENTED IN MANUFACTURE REPORT NUMBER 2919069-2016-02127) SID (B)(6): 2.10. THE PATIENT RECEIVED THE TRANSFUSION ON (B)(6) 2016 AT 1:20 AM. AFTER THE PATIENT RECEIVED THE TRANSFUSION THE BLOOD FILM FROM SPECIMEN ID (B)(6) WAS REVIEWED BY THE CLINICAL HEMATOLOGIST; IT WAS INDICATED THAT THEY OBSERVED GIANT PLATELETS AND ESTIMATED THE ACTUAL PLATELET COUNT TO BE 50 X10X9/L. A NEW SPECIMEN WAS COLLECTED ON (B)(6) 2016, AFTER TRANSFUSION, GENERATING A RESULT OF 86.2. ON (B)(6) 2016 THE PATIENT RETURNED TO THE LABORATORY AND WAS RETESTED. SID (B)(6) GENERATED A RESULT OF 1.59 10X9/L. THIS RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. A HEMATOLOGIST COMPLETED A MANUAL COUNT AND ESTIMATED IT TO BE 60 X10X9/L, DOCUMENTING THE PRESENCE OF GIANT PLATELETS. PER DFP01.014 EDITION 014, THE DATA PROVIDED MEETS PLATELET REPORTING CRITERIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613414 CELL-DYN RUBY ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION 00380740017170

    Patients

    Seq Age Sex Outcome Treatment
    1 Other