BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINITEK STATUS

    MDR report key: 3698807 · Received March 25, 2014

    Report

    Report Number
    1217157-2014-00045
    Event Type
    Malfunction
    Date Received
    March 25, 2014
    Date of Event
    March 7, 2014
    Report Date
    March 7, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    KQO
    PMA / PMN Number
    K031947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER INDICATED THAT THEY WERE TESTING A PATIENT SAMPLE THAT MOST LIKELY CONTAINING A COLOR INTERFERANT HENCE THE RED-ORANGE COLOR. CUSTOMER HAS BEEN INFORMED THAT RUNNING ABNORMALLY COLORED URINE ON THE INSTRUMENT IS NOT RECOMMENDED AND THEY SHOULD INSTEAD SEND THOSE SAMPLES TO A REFERENCE LAB. AS PER REAGENT IFU: SUBSTANCES THAT CAUSE ABNORMAL URINE COLOR MAY AFFECT THE READABILITY OF TEST PADS ON URINALYSIS REAGENT STRIPS. THESE SUBSTANCES INCLUDE VISIBLE LEVELS OF BLOOD OR BILIRUBIN AND DRUGS CONTAINING DYES (E.G., PYRIDIUM, AZO GANTRISIN, AZO GANTANOL), NITROFURANTOIN (MACRODANTIN, FURADANTIN), OR RIBOFLAVIN. CUSTOMER HAS ALSO BEEN OFFERED UPGRADED SOFTWARE WHICH WILL FLAG STRIP(E50) ERROR. CUSTOMER MUST MAKE SURE THAT THEY ARE FOLLOWING THE PROPER DIPPING / TESTING TECHNIQUE ESPECIALLY PAYING CLOSE ATTENTION TO THE DRAGGING THE STRIP EDGE ALONG THE TOP OF THE SAMPLE CONTAINER TO REMOVE AS MUCH OF THE EXCESS FLUID FROM THE STRIP AS POSSIBLE. INSTRUMENT IS PERFORMING AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A MULTISTIX 10SG DIPSTICK READ ERRONEOUSLY AS A MULTISTIX PRO 10LS DIPSTICK ON THE INSTRUMENT. CUSTOMER INDICATED THAT PATIENT WAS NOT TREATED BASED ON THAT RESULTS. THERE WAS NO REPORT OF INJURY FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175719 CLINITEK STATUS CT STATUS KQO SIEMENS HEALTHCARE DIAGNOSTICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1