BEUDAMED
    FDA Adverse Event Summary report: N

    CLINITEK STATUS

    MDR report key: 4178535 · Received October 16, 2014

    Report

    Report Number
    1217157-2014-00160
    Date Received
    October 16, 2014
    Date of Event
    August 4, 2014
    Report Date
    September 26, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    KQO
    PMA / PMN Number
    K031947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING STRIPS WERE RECEIVED FROM CUSTOMER FOR INVESTIGATION: 2X 304115 (10/2014) 44 STRIPS AND 67 STRIPS; 1X 307019 (12/2014) 24 STRIPS WHERE 1 HAD BENT HANDLE TYPICAL OF GETTING STRIP STUCK IN THE BOTTLE CAP. 1X 311072 (5/2015) 4 STRIPS; 1X 210090 (4/2014) EXPIRED - 51 STRIPS. SIEMENS EVALUATED ALL STRIPS AND FOUND OUT THAT STRIPS WERE VISUALLY DETERIORATED IN ALL BOTTLES. NO ISSUES NOTED WITH THE CAPS, CAP LINERS OR BOTTLES. DETERIORATED STRIPS ARE INDICATIVE OF POOR STORAGE CONDITIONS OR LEAVING THE CAP OFF OF THE BOTTLE FOR AN EXTENDED PERIOD OF TIME. AS PER MULTISTIX STRIPS INSTRUCTION FOR USE, "DO NOT REMOVE THE STRIP FROM THE BOTTLE UNTIL IMMEDIATELY BEFORE IT IS TO BE USED FOR TESTING. REPLACE THE CAP IMMEDIATELY AND TIGHTLY AFTER REMOVING THE REAGENT STRIP." THE EVENT OCCURRED DUE TO AN OPERATOR ERROR.

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE FALSE POSITIVE NITRITE RESULTS IS UNKNOWN.

    Description of Event or Problem · 1

    CUSTOMER REPORTED FALSE POSITIVE NITRITE RESULTS ON THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659640 CLINITEK STATUS CT STATUS KQO SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1