BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UF-1000I

    MDR report key: 6694778 · Received July 7, 2017

    Report

    Report Number
    1000515253-2017-00030
    Event Type
    Injury
    Date Received
    July 7, 2017
    Date of Event
    June 8, 2017
    Report Date
    January 23, 2018
    Manufacturer
    SYSMEX CORPORATION
    Product Code
    LKM
    PMA / PMN Number
    K070910
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ARTICLE "PSEUDO-OUTBREAK OF EXTREMELY DRUG-RESISTANT PSEUDOMONAS AERUGINOSA URINARY TRACT INFECTIONS DUE TO CONTAMINATION OF AN AUTOMATED URINE ANALYZER" PUBLISHED IN THE JOURNAL OF CLINICAL MICROBIOLOGY ON JANUARY 4, 2012 WAS FOUND DURING A LITERATURE SEARCH BY A SYSMEX CORPORATION ASSOCIATE. THE ARTICLE DESCRIBED THE CONTAMINATION OF URINE SAMPLES THAT WERE ANALYZED ON THE UF-1000I URINE PARTICLE ANALYZER, AND SUBSEQUENTLY CULTURED. THE LAB STATED THAT THE CONTAMINATION DID NOT INFLUENCE THE BACTERIAL COUNTS PROVIDED BY THE ANALYZER, AND RESULTS WERE UNDER THE THRESHOLD OF PATHOLOGICAL BACTERIURIA. THIS LED TO DISCORDANT RESULTS BETWEEN THE SEDIMENT ANALYSIS ON THE UF-1000I AND THE CULTURE. THEY FURTHER STATED THAT THE PSEUDO-OUTBREAK WAS FACILITATED BY THE LABORATORY STAFF NOT OBSERVING STANDARD ROUTINE SAMPLE PROCESSING BY INCORRECTLY RUNNING THE SAMPLES ON THE UF-1000I, AND THEN USING THE SAME SAMPLE FOR CULTURES. P. AERUGINOSA SPECIES CAN FORM BIOFILMS ON PLASTIC DEVICES; HOWEVER, THE BACTERIAL COUNTS PROVIDED BY THE UF-1000I ANALYZER WERE NOT IMPACTED BY THE CONTAMINATION. THE UF-1000I FLUSHES THE HYDRAULIC LINES BETWEEN SAMPLES TO CLEAR PREVIOUSLY ASPIRATED SAMPLES FROM THE SYSTEM, AND DAILY SHUTDOWN USING BLEACH IS INTENDED TO KEEP THE ANALYZER CLEAN AND PREVENT CARRYOVER TO MEET THE SPECIFICATIONS IN THE UF-1000I INSTRUCTIONS FOR USE MANUAL. FOR RBC: 0.1 % OR LESS, OR 5.0/UL OR LESS FOR BACTERIA: 0.05% OR LESS, OR 5.0 UL OR LESS.

    Additional Manufacturer Narrative · 1

    AFTER SYSMEX CORPORATION INVESTIGATION OF THE ALLEGED CROSS-CONTAMINATION DESCRIBED IN THE ARTICLE, ONLY THREE SIMILAR EVENTS WERE IDENTIFIED IN THE COMPLAINTS DATABASE. THE EVENTS REVEALED THAT THE RESULTS WERE FLAGGED, ALERTING THE OPERATOR TO POSSIBLE SAMPLE ABNORMALITY. EACH WERE RESOLVED BY ROUTINE SERVICING OF THE ANALYZER. THE OCCURRENCE RATE IS CONSIDERED VERY LOW. THE UF-1000I ANALYZER IS EQUIPPED WITH 2 PROBES, ONE DEDICATED TO MIXING THE SAMPLES AND THE OTHER FOR ASPIRATING THE SAMPLES. BOTH OF THE PROBES ARE RINSED PRIOR TO HANDLING THE NEXT SAMPLE. NO FAILED BACKGROUND COUNTS WERE REPORTED BY THE USER. NO SYSTEMIC ANALYZER ISSUE WAS IDENTIFIED AND NO CORRECTIVE ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE UF-1000I IS AN AUTOMATED URINE ANALYZER FOR IN VITRO DIAGNOSTIC USE FOR URINALYSIS IN CLINICAL LABORATORIES TO SCREEN SPECIMENS CONTAINING CERTAIN UNEXPECTED OR ABNORMAL MICROSCOPIC ELEMENTS. ALL FINDINGS MUST BE CORRELATED WITH OTHER CLINICAL SIGNS AND SYMPTOMS PRIOR TO DIAGNOSIS AND TREATMENT. DECONTAMINATION WITH A BROAD-SPECTRUM DISINFECTANT AND THE REPLACEMENT OF THE TUBING WAS PERFORMED ON THE ANALYZER. THIS IS AN MDR-REPORTABLE EVENT DUE TO ADMINISTRATION OF UNNECESSARY ANTIBIOTICS TO A PATIENT BASED ON A FALSE POSITIVE RESULT FOR BACTERIA.

    Description of Event or Problem · 1

    FROM (B)(6), 2010, A HOSPITAL-BASED OUTBREAK OF EXTREMELY DRUG-RESISTANT (XDR) PSEUDOMONAS AERUGINOSA WAS CONFIRMED AND AN INFECTION CONTROL ALERT WAS ISSUED. IT WAS DISCOVERED THAT A BIOFILM WAS FORMED IN THE FLUID SYSTEM OF THE ANALYZER AND MULTIPLE SPECIMENS WERE CONTAMINATED. ONE PATIENT RECEIVED THE ANTIBIOTIC COLISTIN DUE TO THE FALSE POSITIVE BACTERIA. THERE WAS NO REPORT OF PATIENT HARM DUE TO THE ADMINISTRATION OF ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476278 UF-1000I AUTOMATED URINALYSIS ANALYZER LKM SYSMEX CORPORATION UF-1000I

    Patients

    Seq Age Sex Outcome Treatment
    1 Other