BEUDAMED
    FDA Adverse Event Other Summary report: N

    RAPIDPOINT 405

    MDR report key: 2401770 · Received December 28, 2011

    Report

    Report Number
    1217157-2011-00051
    Event Type
    Other
    Date Received
    December 28, 2011
    Date of Event
    November 15, 2011
    Report Date
    November 24, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.
    Product Code
    GKR
    PMA / PMN Number
    K020616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER REPORTED TO MFR THAT SYS CARTRIDGE WAS REPLACED AND EVENT WAS RESOLVED. INSTRUMENT TRACE LOG BEING PROVIDED TO MFR FOR INVESTIGATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A LOW SODIUM BLOOD GAS RESULT 110,5 AND BEGAN TREATMENT. PHYSICIAN QUESTIONED RESULT AND REQUESTED RETEST ON DIFFERENT INSTRUMENT WITH RESULTS 117,9 MMOL/L. NO PT INJURY WAS REPORTED. CONTROLS AND CALIBRATORS WERE WITHIN RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPIDPOINT 405 RAPIDPOINT 405 GKR SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD. 405

    Patients

    Seq Age Sex Outcome Treatment
    1