BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLINITEK ADVANTUS

    MDR report key: 3031929 · Received March 25, 2013

    Report

    Report Number
    1217157-2013-00044
    Event Type
    Other
    Date Received
    March 25, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 6, 2013
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
    Product Code
    CDM
    PMA / PMN Number
    K063276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT SAMPLE IS UNK.

    Description of Event or Problem · 1

    CUSTOMER REPORTS FALSE NEGATIVE RESULTS FOR LEUKOCYTES ON THE INSTRUMENT AND AS WELL AS WHEN THE STRIP WAS READ MANUALLY (VISUALLY). MICROSCOPIC EXAM REVEALED 15-50 LEUKOCYTES PER FIELD. THERE WAS NO REPORT TO PT CARE AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121616 CLINITEK ADVANTUS CLINITEK ADVANTUS CDM SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS ADVANTUS

    Patients

    Seq Age Sex Outcome Treatment
    1