BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINITEK 50

    MDR report key: 2509412 · Received March 26, 2012

    Report

    Report Number
    1217157-2012-00010
    Event Type
    Malfunction
    Date Received
    March 26, 2012
    Date of Event
    February 24, 2012
    Report Date
    March 2, 2012
    Manufacturer
    BAYER CORP.
    Product Code
    KQO
    PMA / PMN Number
    K960546
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER IS USING URINE STRIPS FROM A DIFFERENT MANUFACTURER ON THE CT50 INSTRUMENT. SIEMENS DOES NOT RECOMMEND USE OF NON SIEMENS BRANDED STRIPS AND THE SYSTEM WAS NOT VALIDATED FOR USE WITH OTHER MANUFACTURER'S STRIPS.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THE URINE STRIPS USED ON THE CLINITEK 50 (CUSTOMER USES ACON INSTEAD OF SIEMENS STRIPS) ALWAYS REPORT POSITIVE FOR GLUCOSE AND KETONES WHEN RUN ON THE INSTRUMENT. WHEN THE ALCON STRIPS ARE READ MANUALLY THE STRIP RESULTS ARE NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINITEK 50 CLINITEK 50 KQO BAYER CORP. CT 50

    Patients

    Seq Age Sex Outcome Treatment
    1