BEUDAMED
    FDA Adverse Event Summary report: N

    CLINITEK ATLAS

    MDR report key: 5038920 · Received August 28, 2015

    Report

    Report Number
    1217157-2015-00125
    Date Received
    August 28, 2015
    Date of Event
    July 31, 2015
    Report Date
    August 26, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    KQO
    PMA / PMN Number
    K932674
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS COMPARING RESULTS TO THE CLINITEK 500 THAT CAN READ TRACE BLOOD FROM STRIP IN ITS OPERATION. THE CUSTOMER THOUGHT THE CLINITEK ATLAS READS WHOLE BLOOD CELLS BUT IT DOES NOT. THE ATLAS READS LYSED RBC'S AND THE CUTOFF ACCORDING THE RSC APPLICATION SPECIALIST IS AROUND 5/HPF. THE APPLICATION SPECIALIST SENT THE SUPERVISOR AT THE SITE THE PACKAGE INSERT FOR THE ALTAS STRIPS VIA EMAIL FOR THEIR REVIEW OF THE METHOD AND CUSTOMER WAS SATISFIED. CUSTOMER AND SIEMENS CUSTOMER SIEMENS ENGINEER DETERMINED THAT THE INSTRUMENT WAS AND HAS BEEN OPERATIONAL. INSTRUMENT IS PERFORMING AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED FALSE NEGATIVE BLOOD RESULTS ON THE ANALYZER. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573195 CLINITEK ATLAS CT ATLAS KQO SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1