BEUDAMED
    FDA Adverse Event Other Summary report: N

    RAPIDPOINT 405

    MDR report key: 2745109 · Received September 7, 2012

    Report

    Report Number
    1217157-2012-00041
    Event Type
    Other
    Date Received
    September 7, 2012
    Date of Event
    August 10, 2012
    Report Date
    August 10, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, MANUFACTURING LTD.
    Product Code
    GKR
    PMA / PMN Number
    K020616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION IS CORRECT ON THE LIS SYSTEM. HOWEVER, THE PRINT OUT FROM THE ANALYZER SHOWS THE SAME PATIENT NAME ON BOTH SAMPLES WHEN THE SECOND SAMPLE RAN WAS FOR SOMEONE WITH A DIFFERENT NAME. CUSTOMER REPORTS SHE HAD MANUALLY ENTERED THE PATIENT ID AND SCANNED THE ACCESSION NUMBER FOR EACH SAMPLE. IF CUSTOMERS PRESS 'PATIENT LIST' 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. CUSTOMER WAS INSTRUCTED TO SCAN THE PATIENT ID AS WELL AS THE ACCESSION NUMBER TO REDUCE ENTRY ERRORS. EXPLAINED TO THE CUSTOMER THAT INCORRECT INFORMATION MAY HAVE BEEN INITIALLY ENTERED THEN, CORRECTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS SAME SAMPLE ON PATIENT RUN TWICE BACK TO BACK ON SYSTEM. BOTH SAMPLES REPORTED SAME PATIENT NAME, BUT DIFFERENT ACCESSION NUMBERS. NO INJURY WAS REPORTED AS PART OF THIS EVENT.

    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