BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICHEM® VELOCITY¿ AUTOMATED URINE CHEMISTRY SYSTEM

    MDR report key: 17305876 · Received July 12, 2023

    Report

    Report Number
    2122870-2023-00080
    Event Type
    Injury
    Date Received
    July 12, 2023
    Date of Event
    June 14, 2023
    Report Date
    July 12, 2023
    Manufacturer
    BECKMAN COULTER IRELAND INC.
    Product Code
    KQO
    UDI-DI
    10837461001751
    PMA / PMN Number
    K171083
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BEC FIELD SERVICE ENGINEER (FSE) WAS AT THE CUSTOMER SITE AND OBSERVED THAT THE ICHEM VELOCITY INSTRUMENT WAS NOT DOSING THE VELOCITY URNALYSIS STRIPS PROPERLY. THE FSE FOUND THAT THE SYRINGE PUMP WAS FAULTY, THE RUBBER STOPPER WAS STUCK INSIDE THE SYRINGE AND WOULD NOT ALLOW THE INSTRUMENT TO FULLY DOSE THE PADS. TO RESOLVE THE ISSUE THE FSE REPLACED THE SYRINGE PUMP, CHECKED FLUID CONNECTIONS AND SPM ALIGNMENTS. TO VERIFY REPAIRS, CONTROLS WERE RUN AND PASSED SUCCESSFULLY. BEC INTERNAL IDENTIFIER - (B)(4). RELATED EVENTS: (B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE NEGATIVE ERRONEOUS RESULTS FOR URINE SAMPLES RUN ON THEIR ICHEM VELOCITY URINE CHEMISTRY ANALYZER. NO FLAGS WERE GENERATED BY INSTRUMENT. THIRTEEN(13) PATIENT RESULTS WERE CONSIDERED TO BE IN QUESTION AND THE CUSTOMER BEGAN URINE CULTURES FOR THEM. THE ORIGINAL SAMPLES THAT HAD BEEN REFRIGERATED WERE RE-RUN WITHIN 24 HOURS. THE CULTURE RESULTS FOR SAMPLE 122316400979 SHOWED MIXED FLORA POSSIBLE CONTAMINATION AND THE PATIENT WAS PRESCRIBED ANTIBIOTICS WITHIN 24 HOURS FROM THE TIME THE ORIGINAL URINALYSIS COLLECTION TOOK PLACE. THERE WERE ANOTHER FIVE (5) PATIENTS THAT REQUIRED ANTIBIOTICS, ONE OF WHICH WAS PRESCRIBED ANTIBIOTICS FOR BACTEREMIA/SEPSIS PRIOR TO THE URINE CULTURE BEING PROCESSED. INDIVIDUAL REPORTS WILL BE FILED FOR THE OTHER FOUR (4) PATIENTS AND WILL BE REFERENCED AS RELATED EVENTS IN SECTION H10. THERE WAS NO ADVERSE EVENT REPORTED FOR ANY OF THE 5 PATIENTS THAT WERE DELAYED IN HAVING ANTIBIOTICS PRESCRIBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748214 ICHEM® VELOCITY¿ AUTOMATED URINE CHEMISTRY SYSTEM AUTOMATED URINALYSIS SYSTEM KQO BECKMAN COULTER IRELAND INC. 2.5 ICHEM VELOCITY INSTRUMENT COMPUTERLESS BRING UP TESTED I 10837461001751

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other