BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICHEM VELOCITY

    MDR report key: 3886273 · Received April 9, 2014

    Report

    Report Number
    2023446-2014-00046
    Event Type
    Malfunction
    Date Received
    April 9, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 1, 2014
    Manufacturer
    IRIS INTERNATIONAL
    Product Code
    LJX
    PMA / PMN Number
    K101852
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ICHEM VELOCITY AUTOMATED URINE CHEMISTRY ANALYZER REPORTING SEVERAL FALSE NEGATIVE ON MULTIPLE ANALYTES, SPECIFICALLY LEUKOCYTE ESTERASE AND BILIRUBIN. NO CHANGE IN PATIENT MANAGEMENT WAS REPORTED NOR ANY DELAY OF RESULTS OR TREATMENT AS A RESULT. THE ERRONEOUS RESULTS GENERATED WERE SENT OUT VIA LIS AND AUTO-FILED IN PATIENT CHARTS (1 OUT OF 4 ERRONEOUS RESULTS CONFIRMED VIA MICROSCOPY), HOWEVER, PHYSICIAN WAS NOTIFIED OF ERRONEOUS RESULTS PRIOR TO REVIEWING THE RESULTS WITH PATIENT. FSE INSPECTED THE UNIT, REPLACED THE MIS-ALIGNED PROBE AND CALIBRATED. SYSTEM WAS OPERATIONAL.

    Description of Event or Problem · 1

    CUSTOMER STATED GETTING ERRONEOUS LEUKOCYTE ESTERASE RESULTS FROM VELOCITY NOT MATCHING MANUAL METHOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216000 ICHEM VELOCITY AUTOMATED URINE CHEMISTRY ANALYZER LJX IRIS INTERNATIONAL 700-7177-001

    Patients

    Seq Age Sex Outcome Treatment
    1