BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UF-5000 FULLY AUTOMATED URINE PARTICLE ANALYZER

    MDR report key: 9655919 · Received January 31, 2020

    Report

    Report Number
    1000515253-2020-00003
    Event Type
    Injury
    Date Received
    January 31, 2020
    Date of Event
    January 2, 2020
    Report Date
    January 31, 2020
    Manufacturer
    SYSMEX CORPORATION, I SQUARE
    Product Code
    LKM
    UDI-DI
    04987562440139
    PMA / PMN Number
    K171883
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER REPORTED THE INITIAL CSF RESULTS TO THE CLINICIAN WITHOUT VERIFYING THE RESULTS. THE ACCURACY OF THE INITIAL CSF RESULTS COULD NOT BE CONFIRMED. NO ANALYZER MALFUNCTION HAS BEEN IDENTIFIED. THE ENGLISH VERSION (USED IN EUROPE) OF THE UF-5000 GENERAL INFORMATION, CHAPTER 1.1, INTENDED USE, DESCRIBES: FULLY AUTOMATED URINE PARTICLE ANALYZER UF-5000 IS AN IN VITRO DIAGNOSTIC INSTRUMENT FOR THE DETERMINATION OF CLINICAL PARAMETERS IN HUMAN URINE AND HUMAN BODY FLUIDS. THE INSTRUMENT CAN ONLY BE USED TO ANALYZE HUMAN URINE, BODY FLUID, AND CONTROL MATERIAL SAMPLES. THE UF-5000 BASIC OPERATION, CHAPTER 3 - ANALYZING SAMPLES, SECTION 3.3 - PREPARING SAMPLES, DESCRIBES: SAMPLES ANALYZED IN THE INSTRUMENT ARE AS FOLLOWS: HUMAN URINE, HUMAN BODY FLUID (INCLUDING CEREBROSPINAL FLUID, SEROUS FLUID (PERITONEAL AND PLEURAL), SYNOVIAL FLUID, AND PERITONEAL DIALYSIS FLUID). ANALYZING CSF AND BODY FLUID SAMPLES ON THE UF-5000 IS NOT CLEARED FOR IVD USE IN THE UNITED STATES. THE NORTH AMERICAN VERSION OF THE UF-5000, GENERAL INFORMATION, CHAPTER 1.1 INTENDED USE STATES: FULLY AUTOMATED URINE PARTICLE ANALYZER IS AN AUTOMATED URINE PARTICLE ANALYZER FOR IN VITRO DIAGNOSTIC USE IN SCREENING PATIENT POPULATIONS FOUND IN CLINICAL LABORATORIES. THE SYSMEX UF-5000 FULLY AUTOMATED URINE PARTICLE ANALYZER ANALYZES THE FOLLOWING PARAMETERS IN URINE SAMPLES: RBC, WBC, EPITHELIAL CELLS, CAST, BACTERIA AND FLAGS THE PRESENCE OF THE FOLLOWING: PATHOLOGIC CAST, CRYSTALS, SPERM, YEAST LIKE CELL AND MUCUS.

    Description of Event or Problem · 1

    AN OPERATOR IN DENMARK ALLEGED A CEREBROSPINAL FLUID (CSF) SAMPLE WAS ANALYZED AND GENERATED FALSELY ELEVATED POLYMORPHONUCLEAR LEUKOCYTES (PMN) AND FALSELY DECREASED MONONUCLEAR CELLS (MN). THERE WERE NO ERROR MESSAGES OR FLAGS WITH THE RESULTS. THESE RESULTS WERE NOT VERIFIED WITH MICROSCOPIC EVALUATION. DUE TO DUE TO THE PATIENT'S CLINICAL SIGNS AND SYMPTOMS AND RESULTS FROM THE CSF SAMPLE, THE PATIENT RECEIVED ANTIBIOTICS AND ANTI-VIRAL TREATMENT BEGINNING ON (B)(6) 2020. ADDITIONAL TESTS FOR BLOOD CULTURE AND CSF CULTURE WERE INITIATED. SIX DAYS LATER, ANOTHER CSF SAMPLE WAS COLLECTED AND ANALYZED, WHICH GENERATED LOWER PMN RESULTS AND HIGHER MN RESULTS AS COMPARED TO THE INITIAL CSF VALUES. THESE RESULTS WERE CONFIRMED BY MICROSCOPIC EVALUATION. ANTIBIOTIC TREATMENT WAS DISCONTINUED AND STEROID TREATMENT WAS STARTED BASED ON THE SECOND CSF SAMPLE RESULTS. NO PATIENT HARM WAS REPORTED BASED ON THE ADMINISTRATION OF ANTIBIOTIC TREATMENT, DELAY OF STEROID TREATMENT OR THE SECOND CSF COLLECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114353 UF-5000 FULLY AUTOMATED URINE PARTICLE ANALYZER URINE PARTICLE COUNTER LKM SYSMEX CORPORATION, I SQUARE UF-5000 04987562440139

    Patients

    Seq Age Sex Outcome Treatment
    1 Other