BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPIDLAB 1265

    MDR report key: 2843617 · Received October 24, 2012

    Report

    Report Number
    1217157-2012-00049
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    July 25, 2012
    Report Date
    July 25, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, MANUFACTURING LTD.
    Product Code
    CHL
    PMA / PMN Number
    K960546
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF CUSTOMERS PRESS 'PATIENT LINK' ON THE DEMOGRAPHICS SCREEN THE SYSTEM WILL PRE-SELECT THE PREVIOUS PATIENT. THEY CAN THEN EITHER PRESS THE 'BACK' BUTTON WHICH WILL IGNORE THIS AND GO BACK TO THE ORIGINAL SCREEN OR THEY CAN PRESS THE GREEN 'CONTINUE' BUTTON WHICH WILL THEN OVERWRITE THE ORIGINAL DATA WITH THE PREVIOUS PATIENT DATA. THE USER MAY PRESS THE 'CONTINUE' BUTTON AND INADVERTENTLY OVERWRITE THE DATA BY MISTAKE. THIS 'PATIENT LIST' BUTTON CAN BE DISABLED IN SETUP WHICH STOPS THIS FROM HAPPENING AND REMOVES THE OPTION FROM THE DEMOGRAPHICS SCREEN. SYSTEM IS FUNCTIONING AS EXPECTED.

    Description of Event or Problem · 1

    INCORRECT PATIENT DEMOGRAPHICS ASSIGNED TO PATIENT ID. NO REPORT OF INJURY WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPIDLAB 1265 RAPIDLAB 1265 CHL SIEMENS HEALTHCARE DIAGNOSTICS, MANUFACTURING LTD. RL1265

    Patients

    Seq Age Sex Outcome Treatment
    1