BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPIDPOINT 405

    MDR report key: 3870329 · Received June 12, 2014

    Report

    Report Number
    1217157-2014-00080
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 16, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    GKR
    PMA / PMN Number
    K020616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER INDICATED THAT THEY CORRECTED THE ACCOUNT# BEFORE INFORMING SIEMENS TECHNICAL SUPPORT CENTER. SIEMENS REPRESENTATIVE INSTRUCTED CUSTOMER TO RESEND PATIENT RESULTS TO DATA MANAGEMENT SYSTEM(LIS). CUSTOMER INDICATED THAT THEY DO NOT HAVE ANY FURTHER ISSUES. THIS EVENT HAS OCCURRED DUE TO AN OPERATOR ERROR.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THEY MANUALLY ENTERED INCORRECT ACCOUNT#(B)(6) INSTEAD OF ACCOUNT#(B)(6) IN PATIENT ID FIELD WHICH WAS TRANSFERRED TO DATA MANAGEMENT SYSTEM AS UNKNOWN. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347439 RAPIDPOINT 405 RP 405 GKR SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1