BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLINITEK STATUS

    MDR report key: 3012073 · Received March 12, 2013

    Report

    Report Number
    1217157-2013-00033
    Event Type
    Other
    Date Received
    March 12, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 22, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    KQO
    PMA / PMN Number
    K031560
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER WAS RUNNING NON-SIEMENS URINE TEST STRIPS WHICH ARE NOT APPROVED FOR USE ON THE CLINITEK STATUS SYSTEM. CUSTOMER WAS INFORMED THAT SIEMENS DOES NOT PROVIDE SUPPORT FOR THE USE OF NON-SIEMENS URINE STRIPS AS THEY ARE NOT APPROVED FOR USE ON THE INSTRUMENT. CUSTOMER AGREED TO ORDER SIEMENS URINE STRIPS THAT ARE APPROVED FOR USE ON THE CLINITEK STATUS SYSTEM.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT ALL GLUCOSE SAMPLES BEING TESTED ON THE CLINITEK STATUS WITH NON-SIEMENS URINE STRIPS HAVE RESULTS OF 100. THE SYSTEM IS PROGRAMMED TO RUN SIEMENS MULTISTIX 10SG URINE STRIPS. NO INFORMATION REGARDING QC ON THE SYSTEM WAS AVAILABLE. THERE WAS NO REPORT OF INJURY FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104352 CLINITEK STATUS CT STATUS KQO SIEMENS HEALTHCARE DIAGNOSTICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1