BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICHEM VELOCITY STRIP

    MDR report key: 5048122 · Received September 1, 2015

    Report

    Report Number
    2023446-2015-00229
    Event Type
    Malfunction
    Date Received
    September 1, 2015
    Date of Event
    August 10, 2015
    Report Date
    August 10, 2015
    Manufacturer
    IRIS INTERNATIONAL
    Product Code
    KQO
    PMA / PMN Number
    K101852
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER LOADED A NEW LOT OF STRIPS IN THE CUSTOMER INSTRUMENT. CUSTOMER TECHNICAL SUPPORT (CTS) ALSO SENT THE CUSTOMER A REPLACEMENT LOT OF STRIPS. 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).

    Additional Manufacturer Narrative · 1

    AFTER FURTHER INVESTIGATION THIS EVENT IS CONSIDERED NOT REPORTABLE. THE LOOSE PADS WERE NOT ON THE INSTRUMENT BUT WERE STILL IN THE ORIGINAL CONTAINER POSING NO RISK TO PATIENT/USER SAFETY. NO ERRONEOUS RESULTS WERE GENERATED. THE NARRATIVE WAS UPDATED TO UPDATE THE FILING DECISION FROM REPORTABLE TO NOT REPORTABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED SEEING A LOOSE URINE CHEMISTRY STRIP PADS IN THE STRIP CONTAINER. THE CUSTOMER WAS USING VELOCITY URINE CHEMISTRY STRIPS, P/N: 800-7204 LOT#: 7204089B, EXPIRATION: 6/01/2016. THE STRIPS HAD NOT BEEN LOADED ONTO THE INSTRUMENT. THERE WERE NO ERRONEOUS PATIENT RESULTS GENERATED OR REPORTED OUT OF THE LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577051 ICHEM VELOCITY STRIP URINE CHEMISTRY STRIP KQO IRIS INTERNATIONAL NA 7204089B

    Patients

    Seq Age Sex Outcome Treatment
    1