BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLINITEK STATUS

    MDR report key: 3009241 · Received March 13, 2013

    Report

    Report Number
    1217157-2013-00036
    Event Type
    Other
    Date Received
    March 13, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 14, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    KQO
    PMA / PMN Number
    K031560
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS STATED IN THE IFU PYRIDIUM CAN INTERFERE WITH THE READING OF THE 10SG STRIPS. 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 BLILRUBIN AND DRUGS CONTAINING DYES (E.G., PYRIDIUM, AZO GANTRISIN, AZO GANTANOL), NITROFURANTOIN (MARCO DAN TIN, FURADANTIN), OR RIBOFLAVIN.

    Description of Event or Problem · 1

    A MISIDENTIFICATION OF A MULTISTIX 10SG URINE STRIP OCCURRED WHEN A SAMPLE WAS RUN ON THE SYSTEM. THE ANALYZER IDENTIFIED THE TEST STRIP AS MULTISTIX PRO 10LB. RESULTS WERE GENERATED FOR THE WRONG STRIP CONFIGURATION. PATIENT WAS REPORTED AS TAKING PYRIDIUM. THERE WAS NO REPORT OF INJURY FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106376 CLINITEK STATUS CT STATUS KQO SIEMENS HEALTHCARE DIAGNOSTICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1