BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICHEM VELOCITY

    MDR report key: 4199724 · Received October 22, 2014

    Report

    Report Number
    2023446-2014-00169
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    September 24, 2014
    Report Date
    September 24, 2014
    Manufacturer
    IRIS DIAGNOSTICS
    Product Code
    KQO
    PMA / PMN Number
    K101852
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A HEALTH CARE PRACTITIONER REPORTED EXPERIENCING A HIGH NUMBER OF PATIENT SAMPLES RESULTING IN +1 BLOOD REACTIONS ON URINE CHEMISTRY STRIPS AND "NEGATIVE TO FEW" BLOOD CELLS SEEN ON MICROSCOPY. ACCORDING TO THE REPORTER, PHYSICIANS HAVE ORDERED MORE FOLLOW-UP PROCEDURES IN RESPONSE TO THE OBSERVED INCREASE IN BLOOD REACTION SENSITIVITY AND WERE RESPONDING TO +1, +2, AND +3 READINGS MORE OFTEN. THE REPORTER ALSO STATED THAT SOME PATIENTS HAD TO GO THROUGH URINE RE-COLLECTION AND RETESTING WITH OTHER MANUFACTURERS' STRIPS (WHICH YIELDED NEGATIVE RESULTS), AND SOME PATIENTS UNDERWENT CYSTOSCOPY. A IRIS FIELD SERVICE ENGINEER (FSE) TESTED THE INSTRUMENT AND FOUND THAT ALL CONTROLS PASSED AND NO PREVIOUS CB CONTROL FAILURES. IRIS IS IN THE PROCESS OF INVESTIGATING THE MATTER FURTHER BUT HAS NOT YET CONFIRMED OR OTHERWISE IDENTIFIED A CAUSE FOR THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671626 ICHEM VELOCITY KQO IRIS DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1