BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLINITEK ATLAS

    MDR report key: 3031899 · Received March 25, 2013

    Report

    Report Number
    1217157-2013-00045
    Event Type
    Other
    Date Received
    March 25, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    KQO
    PMA / PMN Number
    K932674
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE. THE FSE FOUND A LOOSE SCREW ON THE BOTTOM OF THE PUMP SYRINGE, THUS THE PUMP WAS NOT DISPENSING ON THE FIRST PAD OF THE STICK WHICH IS THE LEUKOCYTE PAD. THE FSE TIGHTENED THE SCREW AND THE SYSTEM IS FUNCTIONING AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED FALSE NEGATIVE RESULTS FOR LEUKOCYTES ON SEVERAL SAMPLES. VISUAL EXAMINATION INDICATED LEUKOCYTES WERE PRESENT. MANUAL DIPSTICK RESULTS WERE ALSO POSITIVE FOR LEUKOCYTES. THERE WAS NO REPORT OF INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122360 CLINITEK ATLAS CLINITEK ATLAS KQO SIEMENS HEALTHCARE DIAGNOSTICS CT ATLAS

    Patients

    Seq Age Sex Outcome Treatment
    1