BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOMATED DIGITAL CELL MORPHOLOGY ANALYZER DI-60

    MDR report key: 8669611 · Received June 5, 2019

    Report

    Report Number
    3003630693-2019-00002
    Event Type
    Injury
    Date Received
    June 5, 2019
    Date of Event
    March 23, 2019
    Report Date
    June 5, 2019
    Manufacturer
    CELLAVISION AB
    Product Code
    JOY
    PMA / PMN Number
    K092868
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CELLAVISION DI-60 INSTRUCTIONS FOR USE (IFU), INTRODUCTION, INTENDED USE OF AUTOMATED DIGITAL CELL MORPHOLOGY ANALYZER, STATES THE DI-60 IS AN AUTOMATED DIGITAL CELL MORPHOLOGY ANALYZER THAT LOCATES AND PRESENTS IMAGES OF BLOOD CELLS ON PERIPHERAL BLOOD SMEARS. THE OPERATOR IDENTIFIES AND VERIFIES THE SUGGESTED CLASSIFICATION OF EACH CELL ACCORDING TO TYPE. GENERAL DESCRIPTION OF AUTOMATED DIGITAL CELL MORPHOLOGY ANALYZER DI-60, STATES THE ANALYZER SCANS AND PRESENTS AN OVERVIEW IMAGE OF A USER-DEFINED AREA OF THE SLIDE. APPENDIX G - SLIDE PREPARATION GUIDELINES, NOTES ANALYSIS PROCEEDS FROM A STARTING POINT ON THE SLIDE TOWARD THE THINNER PART OF THE SLIDE. THE DI-60 DOES NOT SCAN THE EDGE OF A SLIDE. GOOD LABORATORY PRACTICE MANDATES USERS SCAN THE FEATHERED EDGE OF A SMEAR AT LOW POWER TO RULE OUT PLT CLUMPING. PLT CLUMPS CAN BE CAUSED BY ABNORMAL PROTEINS IN THE PATIENT'S PLASMA CAUSING PLTS TO CLUMP WHEN EXPOSED TO EDTA ANTICOAGULANT. THE LONGER A SAMPLE IS EXPOSED TO EDTA, MORE CLUMPING CAN OCCUR. WHEN THE SODIUM CITRATE TUBE WAS ANALYZED, THE SAMPLE GENERATED A HIGHER PLT COUNT AS COMPARED TO THE EDTA SAMPLES. THE INVESTIGATION DETERMINED THE DEVICE PERFORMED AS DESIGNED. THE LABORATORY IS CONSIDERING REVIEWING ALL SUSPECT PLT-CLUMPING UNDER A MICROSCOPE TO PREVENT RECURRENCE.

    Description of Event or Problem · 1

    ON (B)(6) 2019, CELLAVISION AB RECEIVED AN E-MAIL FROM SYSMEX AMERICA INC. THAT THEY INTENDED TO REPORT AN INCIDENT OCCURING WITH CELLAVISION'S AUTOMATED DIGITAL CELL MORPHOLOGY ANALYZER: A SAMPLE COLLECTED IN EDTA ANTICOAGULANT WAS ANALYZED ON AN XN-10 HEMATOLOGY ANALYZER AND GENERATED A FALSE LOW PLATELET (PLT) RESULT. THE ANALYZER GENERATED "THROMBOCYTOPENIA" AND "PLT CLUMPS?" FLAGGING, ALERTING THE USER TO VERIFY RESULTS. A SMEAR WAS REVIEWED ON A DI-60 AUTOMATED CELL IMAGING DEVICE AND NO PLT CLUMPING WAS NOTED. THE FALSELY LOW PLT RESULT WAS REPORTED. THREE SUBSEQUENT SAMPLES FROM THE SAME PATIENT WERE COLLECTED IN EDTA AND ANALYZED OVER THE NEXT TWO DAYS. ALL SAMPLES GENERATED FALSELY LOW PLT RESULTS AND "THROMBOCYTOPENIA" AND/OR "PLT CLUMPS" FLAGGING. ALL SAMPLES WERE REVIEWED ON THE DI-60 FOR PLT CLUMPING AND NO PLT CLUMPING WAS OBSERVED. FALSE LOW PLT RESULTS WERE REPORTED FOR ALL SAMPLES. ERRONEOUS LOW PLT RESULTS WERE REPORTED FOR THE ABOVE SAMPLES. NO CORRECTED REPORTS WERE ISSUED. THE PATIENT RECEIVED FIVE UNNECESSARY PLT TRANSFUSIONS. IT IS POSSIBLE THERE WAS ALSO A DELAY IN SURGERY AND PEG TUBE PLACEMENT DUE TO THE INCORRECT RESULTS; HOWEVER, THIS WAS NOT CONFIRMED. NO HARM WAS REPORTED DUE TO THE TRANSFUSIONS. ANOTHER SAMPLE COLLECTED IN EDTA WAS ANALYZED AND GENERATED A FALSE LOW PLT RESULT WITH A "THROMBOCYTOPENIA" FLAG. A SMEAR WAS REVIEWED ON THE DI-60 AND NO PLT CLUMPING WAS NOTED. NO RESULTS WERE REPORTED. A SODIUM CITRATE ANTICOAGULANT TUBE WAS COLLECTED ALONG WITH THE EDTA TUBE. THE SODIUM CITRATE TUBE WAS ANALYZED AND GENERATED A "LEFT SHIFT?" FLAG. THE ANALYZER GENERATED A PLT VALUE WITHIN NORMAL REFERENCE RANGE. THE USER CORRECTED THE PLT RESULT FOR THE SODIUM CITRATE DILUTION AND ACCURATELY REPORTED THE RESULT. ON (B)(6) 2019, A PATHOLOGIST REVIEWED SLIDES MANUALLY FROM THE LAST SAMPLE AND NOTED PSEUDOTHROMBOCYTOPENIA DUE TO PLT CLUMPING. THE USER STATED PLT CLUMPING WAS NOTED ON THE FEATHERED EDGE OF THE SMEAR WHERE THE DI-60 DOES NOT PERFORM ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466139 AUTOMATED DIGITAL CELL MORPHOLOGY ANALYZER DI-60 AUTOMATED CELL-LOCATING DEVICE JOY CELLAVISION AB DI-60

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other