BEUDAMED
    FDA Adverse Event Summary report: N

    CLINITEK ATLAS

    MDR report key: 5068857 · Received September 10, 2015

    Report

    Report Number
    1217157-2015-00132
    Date Received
    September 10, 2015
    Date of Event
    August 14, 2015
    Report Date
    September 10, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    KQO
    PMA / PMN Number
    K932674
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS REPRESENTATIVE HAD CUSTOMER THOROUGHLY CLEAN THE READHEAD ASSEMBLY, SOCKETS AND HEAT FILTER AND ASKED THEM TO INSPECT PIPETTE. CUSTOMER CONFIRMED THAT THERE HAVE BEEN NO FURTHER ISSUES AND SYSTEM IS OPERATIONAL.

    Description of Event or Problem · 1

    CUSTOMER REPORTED 5 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
    600259 CLINITEK ATLAS CT ATLAS KQO SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1