BEUDAMED
    FDA Adverse Event Summary report: N

    CLINITEK STATUS

    MDR report key: 6113759 · Received November 18, 2016

    Report

    Report Number
    3002637618-2016-00156
    Date Received
    November 18, 2016
    Date of Event
    October 26, 2016
    Report Date
    November 18, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    KQO
    PMA / PMN Number
    K031947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER CALLED BACK AND STATED THAT THEY FIGURED OUT WHAT HAPPENED. CUSTOMER INDICATED THAT THERE WERE 2 DIFFERENT SAMPLES ON THE SAME PATIENT AND BOTH SAMPLES RUN USING THE SAME PATIENT ID AND 1 SAMPLE HAD PH OF 6.5 AND NEGATIVE BLOOD AND THE OTHER SAMPLE HAD PH OF 7.0 AND TRACE BLOOD THAT'S WHY THE RESULTS IN LIS WERE 7.0 PH AND TRACE BLOOD BECAUSE THERE WERE 2 DIFFERENT SAMPLES ON SAME PATIENT RUN USING SAME PATIENT NUMBER. SAMPLES TESTED ON DIFFERENT INSTRUMENTS AND DIFFERENT LOCATIONS AND RESULTS FROM THE SECOND LOCATION WENT TO LIS. CUSTOMER CONFIRMED THAT THEY ARE ALL SET AND THERE IS NO PROBLEM WITH INSTRUMENT. INSTRUMENT IS PERFORMING AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT WHEN THEY RAN SAMPLE ON INSTRUMENT, USING MULTISTIX 10SG STRIPS, BLOOD RESULT PRINTED OUT AS NEGATIVE AND PH PRINTED OUT AS 6.5 WHEREAS RESULTS IN THE LIS WERE TRACE AND 7.0 FOR BLOOD AND PH RESPECTIVELY. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764579 CLINITEK STATUS CT STATUS KQO SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1