BEUDAMED
    FDA Adverse Event Other Summary report: N

    CT SATUS

    MDR report key: 1731403 · Received June 17, 2010

    Report

    Report Number
    1217157-2010-00010
    Event Type
    Other
    Date Received
    June 17, 2010
    Date of Event
    May 26, 2010
    Report Date
    May 26, 2010
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS, LTD.
    Product Code
    LCX
    PMA / PMN Number
    K031947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE MANUFACTURE DATE: 06/2009.

    Description of Event or Problem · 1

    CUSTOMER REPORTED 2 RECENT FALSE NEGATIVE CLINITEST HCG RESULTS. THERE WAS NO KNOWN ADVERSE IMPACT TO EITHER PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CT SATUS CLINITEK STATUS ANALYZER LCX SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1