BEUDAMED
    FDA Adverse Event Summary report: N

    RAPIDPOINT 405

    MDR report key: 4261099 · Received November 19, 2014

    Report

    Report Number
    1217157-2014-00173
    Date Received
    November 19, 2014
    Date of Event
    October 18, 2014
    Report Date
    October 20, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    GKR
    PMA / PMN Number
    K020616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER SHOULD NOT HAVE RUN PATIENT SAMPLES WHEN AUTOMATIC QUALITY CONTROL (AQC) LEVEL 2 AND LEVEL 3 RESULTS FAILED FOR PH. SIEMENS REPRESENTATIVE CHECKED THE INSTRUMENT AND FOUND OUT THAT SYSTEM WAS ON "UNRESTRICTED" MODE SO CHANGED IT TO "RESTRICTED" MODE. CUSTOMER HAS BEEN INSTRUCTED TO PUT SECURITY MEASURES IN PLACE FOR ONLY DESIGNATED OPERATORS TO BE ABLE TO PERFORM CERTAIN ACTIONS. INSTRUMENT IS WORKING AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THEY RE-ENABLED SENSOR FOR PH WHEN AUTOMATIC QUALITY CONTROL (AQC) LEVEL 2 AND LEVEL 3 FAILED FOR PH ON THE INSTRUMENT. CUSTOMER REPORTED THAT 10 PATIENT SAMPLES WERE RUN DURING THE TIME OF THE AQC PH FAILED AND BEING RESTORED. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749566 RAPIDPOINT 405 RP 405 GKR SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1