BEUDAMED
    FDA Adverse Event Death Summary report: N

    CELL-DYN RUBY ANALYZER

    MDR report key: 5299420 · Received December 15, 2015

    Report

    Report Number
    2919069-2015-00089
    Event Type
    Death
    Date Received
    December 15, 2015
    Date of Event
    October 25, 2015
    Report Date
    December 15, 2015
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PROVIDED NO RETURNS AND NO ADDITIONAL INFORMATION FOR THIS EVALUATION. A HISTORICAL PRODUCT DATA REVIEW WAS PERFORMED FOR THE ANALYZER AND A HISTORICAL REVIEW OF COMPLAINTS AS WELL AS A REVIEW OF ADVERSE EVENTS FOR THE CELL-DYN RUBY ANALYZER. NO SIMILAR EVENTS WERE FOUND. A PRODUCT ISSUE WAS NOT IDENTIFIED FOR THE CELL-DYN RUBY ANALYZER. THE CELL-DYN RUBY SYSTEM OPERATOR'S MANUAL PROVIDES INFORMATION TO ADDRESS THE CURRENT CUSTOMER ISSUE. THE INFORMATION FROM THE CUSTOMER SITE INDICATES THAT THE RESULTS (PARTICULARLY THE HEMAGLOBIN AND PLATELETS) WERE DUE TO THE PATIENT'S CONDITION (BLEEDING) AND THE TRANSFUSION GIVEN. HOWEVER, DUE TO THE LACK OF INFORMATION PROVIDED, IT CANNOT BE COMPLETELY RULED OUT THAT THE CELL-DYN RUBY ANALYZER DID IMPACT PATIENT MANAGEMENT AND COULD HAVE CAUSED/CONTRIBUTED TO THE PATIENT'S DEATH. THE ANALYZER DID FLAG RESULTS, WHICH SHOULD HAVE BEEN ACTED UPON FURTHER BEFORE REPORTING THE RESULTS FROM THE LAB AS INDICATED IN THE CELL-DYN RUBY SYSTEM OPERATOR'S MANUAL. IN THIS REGARD, A USE ERROR IS IDENTIFIED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT A (B)(6) PREGNANT FEMALE PATIENT WAS SEEN IN THE EMERGENCY DEPARTMENT AND GENERATED A HEMOGLOBIN RESULT OF 9.780 G/DL WITH A WBC COUNT OF 42.03 K/UL ON A CELL-DYN RUBY ANALYZER. THE PATIENT WAS REFERRED TO A GENERAL SURGEON BECAUSE OF THE ELEVATED WBC COUNT AND BECAUSE AN ULTRASOUND FOUND FLUID AROUND THE LIVER WITH EVIDENCE OF BLEEDING. A SECOND BLOOD SAMPLE TAKEN (APPROXIMATELY 8 HOURS LATER) GENERATED A HEMOGLOBIN RESULT OF 4.753 G/DL, WHICH CORRELATED TO BLOOD GAS RESULTS. A BLOOD TRANSFUSION WAS GIVEN AND A THIRD SAMPLE TAKEN APPROXIMATELY TWO HOURS LATER GENERATED A HEMOGLOBIN RESULT OF 7.193 G/DL. THE FEMALE PATIENT AND FETUS DIED AS A RESULT OF THE BLEEDING WITH CAUSE OF DEATH CITED AS DISSEMINATED INTRAVASCULAR COAGULATION. THE FOLLOWING IS A CHRONOLOGY OF RESULTS PROVIDED BY THE CUSTOMER: DATE/TIME:(B)(6) 2015 11:33: HGB= 9.780, SN: (B)(4); DATE/TIME:(B)(6) 2015 19:48: HGB= 4.753, SN: (B)(4); DATE/TIME:(B)(6)2015 21:42: HGB= 7.193, SN: (B)(4); DATE/TIME:(B)(6) 2015 23:15: HGB= 2.287, SN: (B)(4); DATE/TIME:(B)(6) 2015 01:30: HGB= 1.321, SN: (B)(4); DATE/TIME:(B)(6) 2015 02:03: HGB= 7.087, SN: (B)(4). HGB= HEMOGLOBIN IN G/DL; CUSTOMER REFERENCE RANGE: 10.8-14.2. THE CUSTOMER WOULD NOT DISCLOSE THE CONDITION OF THE PATIENT AND THE TREATMENTS ADMINISTERED DURING THE ABOVE TIMEFRAMES. IN ALL THE RUNS DOCUMENTED, THE HEMOGLOBIN RESULTS WERE FLAGGED, INDICATING THAT ADDITIONAL VERIFICATION WAS NEEDED; HOWEVER, NO DATA WAS PROVIDED TO CONFIRM IF REPEAT RUNS OR SMEAR REVIEWS WERE PERFORMED. QUALITY CONTROLS SAMPLES WERE WITHIN SPECIFICATIONS ON ALL RUNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828750 CELL-DYN RUBY ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Death