BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICHEM VELOCITY STRIP

    MDR report key: 4958342 · Received July 31, 2015

    Report

    Report Number
    2023446-2015-00213
    Event Type
    Malfunction
    Date Received
    July 31, 2015
    Date of Event
    July 21, 2015
    Report Date
    July 21, 2015
    Manufacturer
    IRIS INTERNATIONAL
    Product Code
    KQO
    PMA / PMN Number
    K101852
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE WAS NOT SENT TO THE CUSTOMER LOCATION. THE CUSTOMER WAS TROUBLESHOOTING A SYSTEM ERROR WITH CUSTOMER TECHNICAL SUPPORT (CTS) AND DURING CLEANING SAW THE STRIP PADS AT THE BOTTOM OF THE INSTRUMENT. THE TROUBLESHOOTING WAS UNRELATED TO THE PADS FOUND IN THE CUSTOMER INSTRUMENT. UNDER CORRECTIVE AND PREVENTIVE ACTION PROGRAM THIS ISSUE IS BEING INVESTIGATED AND ACTIONS ARE BEING IMPLEMENTED. UPON ANALYZING THE KEY PROCESSES, ENHANCEMENT ACTIONS PERTAINING TO MANUFACTURING/SUPPLY CHAIN PROCESS PARAMETERS AND QC TEST METHODS ARE BEING INITIATED AND IMPLEMENTED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER FOUND ONE LOOSE VELOCITY URINE CHEMISTRY STRIP PADS IN THE BOTTOM OF THE INSTUMENT. THE LOT NUMBER THE CUSTOMER WAS USING IS P/N: 800-7212 LOT#: 7212052B, EXPIRATION: 3/2016. THERE WERE NO ERRONEOUS PATIENT RESULTS GENERATED OR REPORTED OUT OF THE LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502028 ICHEM VELOCITY STRIP URINE CHEMISTRY STRIP KQO IRIS INTERNATIONAL NA 7212052B

    Patients

    Seq Age Sex Outcome Treatment
    1