BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLINITEK STATUS

    MDR report key: 3054920 · Received April 3, 2013

    Report

    Report Number
    1217157-2013-00049
    Event Type
    Other
    Date Received
    April 3, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    KQO
    PMA / PMN Number
    K091216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER INDICATED THAT THE SAMPLE WAS RED PRIOR TO ANALYSIS. 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. THE CUSTOMER HAS BEEN PREVIOUSLY OFFERED A SOFTWARE UPGRADE THAT WOULD TRIGGER AN ERROR CODE INSTEAD OF PRODUCING RESULTS, IF A 10SG STRIP WAS MISREAD AS A 10LB BUT THE CUSTOMER HAS CHOSEN NOT TO INSTALL THE SOFTWARE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A MULTISTIX 10SG 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
    137544 CLINITEK STATUS CLINITEK STATUS KQO SIEMENS HEALTHCARE DIAGNOSTICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1