BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICHEM VELOCITY

    MDR report key: 3851121 · Received May 22, 2014

    Report

    Report Number
    2023446-2014-00057
    Event Type
    Injury
    Date Received
    May 22, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 24, 2014
    Manufacturer
    IRIS INTERNATIONAL
    Product Code
    KQO
    PMA / PMN Number
    K101852
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FALSE POSITIVE BLOOD IN URINE CHEMISTRY OF ONE PT LED TO AN UNNECESSARY KIDNEY BIOPSY, ACCORDING TO CUSTOMER, RESULTING IN AN UNK COMPLICATION. A COMPLICATION OCCURRED AS A RESULT OF THE BIOPSY. THE URINE MICROSCOPY SHOWED NO RBCS OR LITTLE RBCS PRESENT IN THE PT'S URINE. THE CUSTOMER, DESPITE REPEATED ATTEMPTS, HAS NOT CLARIFIED SPECIFICALLY WHAT COMPLICATION OCCURRED. THERE HAVE BEEN NO REPORTS OF MED INTERVENTION TAKEN AS A RESULT OF THE BIOPSY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT BASED ON HIGH RBC VALUE, PHYSICIAN ORDERED UNNECESSARY BIOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306564 ICHEM VELOCITY AUTOMATED URINE CHEMISTRY ANALYZER KQO IRIS INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other