BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLINITEK ATLAS

    MDR report key: 3012062 · Received March 12, 2013

    Report

    Report Number
    1217157-2013-00032
    Event Type
    Other
    Date Received
    March 12, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 22, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    KQO
    PMA / PMN Number
    K932674
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER WAS DISPATCHED TO THE SITE AND DISCOVERED A BENT PIPETTE. PIPETTE WAS REPLACED AND ALIGNMENT OF SAMPLE PIPETTE WAS ADJUSTED. RINSE WELL WAS CLEANED. CALIBRATION AND CONTROLS WERE RUN AND SYSTEM IS OPERATIONAL.

    Description of Event or Problem · 1

    TWO SAMPLES TESTED ON SAME PATIENT ON THE SAME DAY HAD NEGATIVE RESULTS FOR PROTEIN. THE PHYSICIAN QUESTIONED THE NEGATIVE RESULTS AS THE PATIENT HAS A HISTORY OF HIGH URINE PROTEINS. EACH SAMPLE WAS RETESTED LATER THAT DAY AFTER BEING BROUGHT TO ROOM TEMPERATURE. EACH SAMPLE TESTED 3+ FOR URINE PROTEIN AND CLARITY OF CLOUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104333 CLINITEK ATLAS CLINITEK ATLAS KQO SIEMENS HEALTHCARE DIAGNOSTICS CT ATLAS

    Patients

    Seq Age Sex Outcome Treatment
    1