BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINITEK 500

    MDR report key: 2962099 · Received January 22, 2013

    Report

    Report Number
    1217157-2012-00078
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    November 30, 2012
    Report Date
    November 30, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    CHL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER REPORTS THEY USE BLEACH TO CLEAN THE TABLES AFTER INSTRUMENT TESTING. CUSTOMER WAS ADVISED TO CLEAN THE TABLES WITH LIQUID SOAP AND WATER WITH A FINAL RINSE OF DH20. CUSTOMER WAS ADVISED THAT ANTIBIOTICS MAY CAUSE FALSE NEGATIVE RESULTS. CUSTOMER WAS FURTHER ADVISED TO REVIEW LIMITATION SECTION OF THE PACKAGE INSERT. CUSTOMER WAS FURTHER ADVISED TO CONTINUE TO MONITOR RESULTS. CUSTOMER REPORTED THAT CO-WORKER NOTED AND CONFIRMED THAT MOT FALSE NEG LEUK READ BY ANALYSER WERE DUE TO ANTIBIOTIC INTERFERENCE.

    Description of Event or Problem · 1

    DISCREPANT RESULTS FOR LEUKOCYTE. CUSTOMER REPORTS THREE URINE SAMPLES REPORTED NEGATIVE FOR LEUKOCYTES. FURTHER MICROSCOPIC EXAMINATION ON THE SAMPLES WAS POSITIVE FOR LEUKOCYTES. NO REPORT OF INJURY WITH THE EVENT. MICROSCOPIC RESULTS WERE REPORTED TO THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29998 CLINITEK 500 CLINITEK 500 CHL SIEMENS HEALTHCARE DIAGNOSTICS CT 500

    Patients

    Seq Age Sex Outcome Treatment
    1