BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINITEK STATUS

    MDR report key: 3894778 · Received June 25, 2014

    Report

    Report Number
    1217157-2014-00089
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    March 20, 2014
    Report Date
    June 4, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    KQO
    PMA / PMN Number
    K031947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER TOOK INSTRUMENT OUT OF SERVICE AFTER RECEIVING TEST RESULTS. NO ADDITIONAL INFORMATION HAS BEEN MADE AVAILABLE BY CUSTOMER.

    Additional Manufacturer Narrative · 1

    CUSTOMER CHANGED THEIR CLEANING PROCEDURE FROM USING REGULAR WATER TO DISTILLED WATER WHEN CLEANING THE TEST TABLE AND USING PROPER CLEANING TECHNIQUES IS WHAT RESOLVED THE ISSUE. INSTRUMENT IS WORKING AS INTENDED. CUSTOMER REITERATED THAT THERE HAVE BEEN NO ISSUES WITH RESULTS SINCE THIS CHANGE.

    Description of Event or Problem · 1

    CUSTOMER RECEIVED FALSE NEGATIVE RESULTS FOR LEUKOCYTES WHEARAS RESULTS IN REFERENCE LAB WAS POSITIVE. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369907 CLINITEK STATUS CT STATUS KQO SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1