BEUDAMED
    FDA Adverse Event Other Summary report: N

    RAPIDPOINT 400 SYSTEM

    MDR report key: 1581782 · Received January 15, 2010

    Report

    Report Number
    1217157-2010-00002
    Event Type
    Other
    Date Received
    January 15, 2010
    Date of Event
    December 16, 2009
    Report Date
    December 16, 2009
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS, LTD.
    Product Code
    CHL
    PMA / PMN Number
    K002738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CAPILLARY SAMPLES FROM NEONATES GAVE SPORADIC HIGH SODIUM RESULTS. HIGH SODIUM RESULT SAMPLES WERE RERUN USING LAB METHOD (INDIRECT ISE ON OLYMPUS) TO CONFIRM.

    Description of Event or Problem · 1

    CUSTOMER REPORTS SPORADIC DISCORDANT SODIUM RESULTS ON NEONATE BLOOD SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPIDPOINT 400 SYSTEM RAPIDPOINT 400 SYSTEM CHL SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS, LTD. RP 400

    Patients

    Seq Age Sex Outcome Treatment
    1