BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICHEM VELOCITY STRIP

    MDR report key: 4958340 · Received July 31, 2015

    Report

    Report Number
    2023446-2015-00211
    Event Type
    Malfunction
    Date Received
    July 31, 2015
    Date of Event
    July 8, 2015
    Report Date
    July 13, 2015
    Manufacturer
    IRIS INTERNATIONAL
    Product Code
    KQO
    PMA / PMN Number
    K101852
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE WAS NOT SENT TO THE CUSTOMER LOCATION. THE CUSTOMER IS GOING TO CONTINUE TO MONITOR THE INSTRUMENT FOR LOOSE PADS. 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. BEC INTERNAL IDENTIFIER FOR THIS REPORT IS (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER FOUND LOOSE VELOCITY URINE CHEMISTRY STRIP PADS IN THE STRIP PROVIDER MODULE(SPM). THE LOT NUMBER THE CUSTOMER WAS USING IS P/N: 800-7212 LOT#: 7212058A, EXPIRATION: 4/29/2016. THERE WERE NO ERRONEOUS PATIENT RESULTS GENERATED OR REPORTED OUT OF THE LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502265 ICHEM VELOCITY STRIP URINE CHEMISTRY STRIP KQO IRIS INTERNATIONAL NA 7212058A

    Patients

    Seq Age Sex Outcome Treatment
    1