BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLINITEK STATUS

    MDR report key: 3190176 · Received June 18, 2013

    Report

    Report Number
    1217157-2013-00105
    Event Type
    Other
    Date Received
    June 18, 2013
    Date of Event
    December 18, 2011
    Report Date
    December 18, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    KQO
    PMA / PMN Number
    K031947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER HAS BEEN RE-TRAINED FOR PROPER SAMPLING TECHNIQUE. CUSTOMER IS BEING PROVIDED WITH SOFTWARE THAT WILL GENERATE AN ERROR CODE (E50) ERROR INSTEAD OF MISIDENTIFYING THE STRIP.

    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
    276697 CLINITEK STATUS CT STATUS KQO SIEMENS HEALTHCARE DIAGNOSTICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1