BEUDAMED
    FDA Adverse Event Other Summary report: N

    RAPIDPOINT 405

    MDR report key: 3131279 · Received May 13, 2013

    Report

    Report Number
    1217157-2013-00082
    Event Type
    Other
    Date Received
    May 13, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    CHL
    PMA / PMN Number
    K002738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCORRECT PATIENT DEMOGRAPHICS ARE DUE TO OPERATOR ERROR. SIEMENS FIELD ENGINEER CHECKED THE DATA LOG FILE BETWEEN THE RP405 ANALYZER AND THE RAPIDCOMM AND FOUND THAT THE ANALYZER WAS SENDING THE CORRECT PATIENT DATA, BUT THE OPERATOR WAS SELECTING THE "LAST PATIENT" BUTTON ON THE DEMOGRAPHICS SCREEN WHILE THE SAMPLE WAS RUNNING. THE CUSTOMER WAS INSTRUCTED TO DESELECT THE "LAST PATIENT" BUTTON. INSTRUMENT IS PERFORMING ITS INTENDED USE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT DIFFERENT PATIENT DEMOGRAPHICS WERE OBSERVED BETWEEN THE RP405 ANALYZER AND THE RAPIDCOMM. THERE WAS NO REPORT OF INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211704 RAPIDPOINT 405 RAPIDPOINT 405 CHL SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1