BEUDAMED
    FDA Adverse Event Death Summary report: N

    CELL-DYN RUBY ANALYZER

    MDR report key: 5858237 · Received August 9, 2016

    Report

    Report Number
    2919069-2016-02061
    Event Type
    Death
    Date Received
    August 9, 2016
    Date of Event
    July 11, 2016
    Report Date
    May 1, 2017
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K061667
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION INCLUDED REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, A REVIEW OF PRODUCT HISTORICAL DATA, REVIEW OF LABELING, AND CONSULTATION WITH MEDICAL AFFAIRS. A REVIEW COMPLETED FOR COMPLAINTS AND BATCH RECORDS DID NOT IDENTIFY ANY ADVERSE TRENDS. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS COMPLAINT INVESTIGATION, NO MALFUNCTION AND NO PRODUCT DEFICIENCY WAS IDENTIFIED. ABBOTT MEDICAL REVIEW OF THE COMPLAINT AND PATIENT HISTORY CONCLUDED THE FOLLOWING; REVIEW OF THE SUBMITTED DATA AND PATIENT INFORMATION INDICATED IT IS POSSIBLE THAT PATIENT DEHYDRATION AT THE TIME OF THE INITIAL BLOOD DRAW ON (B)(6) 2016 MAY HAVE CAUSED THE PLATELET CONCENTRATION TO INCREASE, RESULTING IN THE HIGH COUNT. DURING THE 23 HOUR GAP BETWEEN THE 2 BLOOD DRAWS, THE PATIENT RECEIVED INTRAVENOUS FLUIDS THAT MAY HAVE DILUTED THE PATIENT BLOOD SAMPLE THAT WAS DRAWN AND TESTED ON (B)(6) 2016, WHICH GENERATED A LOW PLATELET COUNT. IN ADDITION, THE MULTIPLE ORGAN FAILURES AND CONTINUED DECLINE OF THE CONDITION OF THE PATIENT MAY HAVE BEEN DUE TO CLOTTING, THROMBOSIS, AND WIDESPREAD THROMBOTIC EVENTS, WHICH COULD HAVE BEEN A CONTRIBUTING FACTOR TO THE LOWER PLATELET COUNT ON (B)(6) 2016 THAN ON (B)(6) 2016. THE DEFINITIVE CAUSE FOR THE DIFFERENT PLATELET RESULTS COULD NOT BE DETERMINED. SECTION A. PATIENT INFORMATION 1. PATIENT IDENTIFIER INCLUDED TWO NUMBERS (B)(6).

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION WAS REASSESSED AND CONCLUDED THAT A MALFUNCTION OCCURRED, THE DEVICE DID NOT PERFORM AS INTENDED. HOWEVER, NO SYSTEMATIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED. CONCLUSION CODE WAS CORRECTED.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT DIED ON (B)(6) 2016 OF MULTI-ORGAN FAILURE. PER THE HOSPITAL DISCHARGE SUMMARY / DEATH NOTIFICATION, CASE SUMMARY: THE PATIENT WAS A GRAVELY DEBILITATED (B)(6) FEMALE WHO HAD AN EXTENSIVE AND COMPLEX MEDICAL HISTORY, THAT INCLUDED UNDERLYING CONDITIONS THAT CONTRIBUTED TO THE CAUSE OF DEATH. THE UNDERLYING CONDITIONS INCLUDED THE FOLLOWING. ADVANCED DEMENTIA. DEHYDRATION, SECONDARY TO POOR ORAL INTAKE 4 DAYS PRECEDING ADMISSION. URINARY TRACT INFECTION. CORONARY ARTERY DISEASE, HISTORY OF STENT PLACEMENT. ADVANCED DYSPHAGIA. DIABETES MELLITUS TYPE 2. ATRIAL FIBRILLATION. CEREBROVASCULAR DISEASE WITH HISTORY OF CVA AND RESIDUAL LEFT HEMIPARESIS. CHRONIC THROMBOCYTOPENIA. HISTORY OF PEPTIC ULCER DISEASE. HYPERSENSITIVITY VASCULITIS WITH NECROSIS. DRESS / DRUG-INDUCED IMMUNE REACTION SPECTRUM STATUS POST IVIG. THE PATIENT WAS ADMITTED ON (B)(6) 2016 WITH A URINARY TRACT INFECTION, FOR APPARENT DEHYDRATION, DECREASED P.O. INTAKE, AND PROGRESSIVE DYSPHAGIA WITH NOTED GAGGING ON FOODS AND LIQUIDS. HER CONDITION CONTINUED TO DECLINE DURING HER HOSPITAL COURSE UNTIL SHE RAPIDLY DECOMPENSATED AS NOTED BY PROFOUND HYPOTENSION AND DRAMATIC DECLINE IN HER BLOOD COUNTS THE DAY PRIOR TO HER DEATH. THE DECISION WAS MADE TO DISCONTINUE ALL AGGRESSIVE MEDICAL THERAPIES AND TRANSITION HER TO COMFORT CARE. THIS WAS NOT AN UNEXPECTED DEATH. BLOOD SAMPLES FROM THE PATIENT WERE TESTED ON (B)(6) 2016. THE CUSTOMER OBSERVED FALSELY ELEVATED PLATELET COUNTS (PLT) FOR THE PATIENT GENERATED USING THE CELL-DYN RUBY ANALYZER. THE FOLLOWING DATA WAS PROVIDED. THE CUSTOMER USES NORMAL RANGE 150 TO 375 10E3/UL. (B)(6) TESTED ON (B)(6) 2016 RESULT 293 (10E3/UL). (B)(6) TESTED ON (B)(6) 2016 RESULT 8 (10E3/UL). A STAINED SMEAR WAS PERFORMED ON (B)(6) 2016 AND CONFIRMED THE LOW PLATELET RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512838 CELL-DYN RUBY ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death