BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINITEK STATUS

    MDR report key: 4012085 · Received August 15, 2014

    Report

    Report Number
    1217157-2014-00115
    Event Type
    Malfunction
    Date Received
    August 15, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 29, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    KQO
    PMA / PMN Number
    K031947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS BEEN INFORMED NOT TO RUN ABNORMALLY COLORED URINE SAMPLES ON INSTRUMENT PARTICULARLY PYRUVATE/PYRIDIUM SAMPLES. 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 BEEN SENT SOFTWARE VERSION 2.4 WHICH WILL TRIGGER ERROR CODE (E50) INSTEAD OF MISIDENTIFICATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE MISIDENTIFICATION OF MULTISTIX 10 SG AS MULTISTIX PRO 10 LB ON THE INSTRUMENT WITH A PYRIDIUM SAMPLE. THERE WAS NO REPORT OF INJURY FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490898 CLINITEK STATUS CT STATUS KQO SIEMENS HEALTHCARE DIAGNOSTICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1