BEUDAMED
    FDA Adverse Event Summary report: N

    CLINITEK STATUS

    MDR report key: 4703937 · Received April 17, 2015

    Report

    Report Number
    1217157-2015-00048
    Date Received
    April 17, 2015
    Date of Event
    March 19, 2015
    Report Date
    March 24, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    KQO
    PMA / PMN Number
    K031947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    QA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER ALLEGED DISCORDANT BLOOD AND PROTEIN RESULTS. THEY INITIALLY HAD MENTIONED THAT LEUKOCYTES ALSO ARE NOT CORRELATING WITH MICROSCOPIC RESULTS, BUT HAVE NOT FOUND ANY ADDITIONAL INFORMATION TO INVESTIGATE. THE EXAMPLE PROVIDED WAS FOUND NOT TO BE A TRUE FALSE NEGATIVE PROTEIN. THERE WAS MISUNDERSTANDING BY THE CUSTOMER OF UNIT CONVERSION. AS PER INVESTIGATION BY SIEMENS HEADQUARTER SUPPORT CENTER TEAM; THE MULTISTIX 10 SG PROTEIN WILL READ NEGATIVE (SENSITIVITY IS 15-30 MG/DL) WHICH WOULD TRANSLATE TO A MICRO ALBUMIN RANGE OF 150-300 MG/L. SO THE EXAMPLES CUSTOMER GAVE OF 45-49 MG/L WOULD BE WELL BELOW THE SENSITIVITY RANGE OF THE MULTISTIX PROTEIN REAGENT. THE CUSTOMER'S ALLEGATIONS OF FALSE POSITIVE BLOOD WERE EXPLAINED AS FOLLOWS: SAMPLE 1: 2-3 RBC/HPF READING TRACE-LYSED. MULTISTIX COULD READ THIS EASILY BECAUSE THE REAGENT DETECTS FREE HEMOGLOBIN WITHIN THE SAMPLE AND WE DO NOT KNOW HOW MANY RBCS WERE ORIGINALLY IN THE SAMPLE THAT LYSED RESULTING IN THE FREE HEMOGLOBIN. DEBRIS FROM LYSED CELLS IS VERY DIFFICULT TO DETECT USING TRADITIONAL LIGHT MICROSCOPY. SAMPLE 2: OCCASIONAL RBC/HPF READING TRACE-INTACT. THIS HAS TO DO WITH THE WAY IT READS THE BLOOD REAGENT. IT TAKES 4 READINGS AT THE RED WAVELENGTH AND THEN CALCULATES THE SD. IF IT IS ABOVE A CERTAIN THRESHOLD THEN IT REPORTS NHT. SO A DOT OR TWO IN THE RIGHT SPOT ON THE PAD MAY GIVE THE NHT READING. SIEMENS PRODUCT IS MEETING ALL ITS SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT BLOOD AND PROTEIN RESULTS IS UNKNOWN.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT BLOOD AND PROTEIN RESULTS WERE NOT CORRELATED TO THE MICROSCOPIC EXAMINATION FOR MULTIPLE PATIENTS. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258271 CLINITEK STATUS CT STATUS KQO SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1