BEUDAMED
    FDA Adverse Event Summary report: N

    CLINITEK ADVANTUS

    MDR report key: 5735319 · Received June 20, 2016

    Report

    Report Number
    1217157-2016-00067
    Date Received
    June 20, 2016
    Date of Event
    April 25, 2016
    Report Date
    June 20, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    KQO
    PMA / PMN Number
    K063276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS REPRESENTATIVE (FSE) REVIEWED TECHNIQUE WITH CUSTOMER. CUSTOMER WAS DIPPING AND RIMMING BUT NOT BLOTTING, PLACING STRIP IMMEDIATELY ON TABLE IN THE PROPER LOCATION. THERE WERE NO OTHER ISSUES OR ERRORS WITH THE INSTRUMENT. FSE ORDERED THE CUSTOMER ONE BOTTLE OF MULTISTIX FOR TROUBLESHOOTING AND ASKED CUSTOMER TO CLEAN THE INSTRUMENT, RUN CONTROLS AND PATIENT SAMPLE TO CHECK THE DIFFERENCE IN RESULTS. CUSTOMER RE-RAN SAMPLE ON THE INSTRUMENT AS INSTRUCTED. FOLLOWING BLOOD RESULTS WERE OBTAINED: ORIGINAL TEST: NEGATIVE (LOT #5110078). RERAN PATIENT SAMPLE ON NEW LOT # 603023: NEGATIVE RESULT. RERAN PATIENT SAMPLE ON LOT #5110078: NEGATIVE RESULT. SENT SAMPLE TO REFERENCE LAB: NEGATIVE RESULT. CUSTOMER INDICATED THAT INSTRUMENT IS FULLY OPERATIONAL AND THEY DO NOT REQUIRE FURTHER FOLLOW UP. THE INSTRUMENT IS FULLY OPERATIONAL AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED FALSE NEGATIVE BLOOD RESULT ON THE ANALYZER WHEN COMPARED TO MICROSCOPIC RESULTS. CUSTOMER INDICATED THAT APPROXIMATELY 8-9 PATIENTS OVER THE LAST 30 DAYS HAD REPORTED NEGATIVE FOR BLOOD AND WHEN MICROSCOPIC WAS DONE BLOOD CELLS WERE VISIBLE. CUSTOMER STATED THAT CLEANING WAS DONE DAILY WITH DI WATER ON FIXED PLATFORM & HOLD DOWN MOVING TABLE AND PUSHBAR. PUSHBAR IS CLEANED AND LUBRICATED MONTHLY. THERE WAS NO REPORT OF INJURY DUE TO ANY OF THESE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390315 CLINITEK ADVANTUS CT ADVANTUS KQO SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1