BEUDAMED
    FDA Adverse Event Other Summary report: N

    RAPIDPOINT 405 SYSTEM

    MDR report key: 1659081 · Received April 8, 2010

    Report

    Report Number
    1217157-2010-00007
    Event Type
    Other
    Date Received
    April 8, 2010
    Date of Event
    March 16, 2010
    Report Date
    March 16, 2010
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS, LTD.
    Product Code
    CHL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER EVALUATING 3 LEVELS OF CONTROLS AND WILL PROVIDE DATA LOG FILES FOR REVIEW. THERE WAS NO IMPACT TO PATIENT CARE AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    AN ELEVATED SODIUM RESULT WAS OBTAINED ON AN ARTERIAL BLOOD SAMPLE FROM A PREMATURE INFANT. THE RESULTS WERE REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. A SERUM SAMPLE WAS OBTAINED WHICH GAVE HIGHER RESULTS BY ALTERNATE METHODOLOGY. A THIRD SAMPLE WAS OBTAINED WHICH GAVE SIMILAR RESULTS TO THE ORIGINAL SAMPLE ON BOTH THE ORIGINAL ANALYZER AND ALTERNATE METHODOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPIDPOINT 405 SYSTEM RAPIDPOINT 405 SYSTEM CHL SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS, LTD. RP 405

    Patients

    Seq Age Sex Outcome Treatment
    1