BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICHEM VELOCITY STRIP

    MDR report key: 4548426 · Received February 20, 2015

    Report

    Report Number
    2023446-2015-00030
    Event Type
    Malfunction
    Date Received
    February 20, 2015
    Date of Event
    January 24, 2015
    Report Date
    January 24, 2015
    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

    Additional Manufacturer Narrative · 1

    CUSTOMER REPORTED STRIP PROVIDER MODULE (SPM) ISSUES. THERE WERE NO REPORTS OF INJURY TO PATIENT OR CHANGE IN PATIENT MANAGEMENT AS A RESULT. DURING ON-SITE UNIT INSPECTION, AN IRIS FIELD SERVICE ENGINEER (FSE) OBSERVED LOOSE STRIP PADS IN THE SPM. FSE CLEANED AND REASSEMBLED THE SPM. SYSTEM WAS OPERATIONAL. THE REASON FOR LOOSE PADS IS UNDER INVESTIGATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED STRIP PROVIDER MODULE (SPM) MOTOR ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124357 ICHEM VELOCITY STRIP KQO IRIS DIAGNOSTICS 7212047A

    Patients

    Seq Age Sex Outcome Treatment
    1