BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLINITEK ATLAS

    MDR report key: 3001517 · Received March 5, 2013

    Report

    Report Number
    1217157-2013-00026
    Event Type
    Other
    Date Received
    March 5, 2013
    Date of Event
    December 20, 2012
    Report Date
    February 4, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    KQO
    PMA / PMN Number
    K932674
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE FALSE NEGATIVE RBC RESULT IS UNK.

    Description of Event or Problem · 1

    FALSE NEGATIVE RBC RESULTS WERE OBSERVED ON THE CLINITEK ATLAS. WHEN SAMPLE WAS EXAMINED MICROSCOPICALLY, THE NUMBER OF RBCS SEEN IS NOT CONSISTENT WITH THE NEGATIVE/TRACE RESULT AS REPORTED BY THE INSTRUMENT. WHEN THE SAMPLE WAS READ MANUALLY, THE SAMPLE STILL GAVE A FALSE NEGATIVE RBC RESULT. THERE WAS NO IMPACT TO PT CARE AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93095 CLINITEK ATLAS CLINITEK ATLAS KQO SIEMENS HEALTHCARE DIAGNOSTICS CT ATLAS

    Patients

    Seq Age Sex Outcome Treatment
    1