BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLINITEK STATUS

    MDR report key: 3215906 · Received July 1, 2013

    Report

    Report Number
    1217157-2013-00117
    Event Type
    Other
    Date Received
    July 1, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 10, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    KQO
    PMA / PMN Number
    K031947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER WAS USING ORANGE COLOR SAMPLE ON THE INSTRUMENT. AS STATED IN THE 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 (MACRO DAN TIN, FURADANTIN), OR RIBOFLAVIN. CUSTOMER WAS INFORMED THAT ANY DISCOLORED SAMPLES SHOULD NOT BE RUN BY THIS METHOD BECAUSE IT IS A COLORIMETRIC TEST. THE CUSTOMER HAS BEEN RE-TRAINED FOR PROPER SAMPLING TECHNIQUE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A MULTISTIX 10LS DIPSTICK READ ERRONEOUSLY AS A MULTISTIX PRO 10LB DIPSTICK ON THE INSTRUMENT. THERE WAS NO REPORT OF INJURY FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297239 CLINITEK STATUS CT STATUS KQO SIEMENS HEALTHCARE DIAGNOSTICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1