BEUDAMED
    FDA Adverse Event Other Summary report: N

    RAPIDPOINT 405

    MDR report key: 3535807 · Received November 22, 2013

    Report

    Report Number
    1217157-2013-00217
    Event Type
    Other
    Date Received
    November 22, 2013
    Date of Event
    October 26, 2013
    Report Date
    October 28, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSITCS
    Product Code
    GKR
    PMA / PMN Number
    K020616
    Removal / Correction Number
    1217157-08-21-2013-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON REVIEW OF LOG FILES, SOFTWARE DEPARTMENT INDICATED THAT THEY WERE UNABLE TO VIEW PT DEMOGRAPHIC DATA IN LOGS BUT WERE ABLE TO DETERMINE THAT "SAVE DEMOGRAPHICS" WAS TURNED ON. THE CUSTOMER WAS INFORMED THAT THE ERRONEOUS PT ID DISPLAYED ON THE INSTRUMENT WAS LIKELY DUE TO THE "PATIENT LIST" BUTTON BEING SELECTED ON THE INSTRUMENT. CUSTOMER HAS BEEN INSTRUCTED TO DISABLE THIS SETTING. CUSTOMER DISABLED THE SETTING. INSTRUMENT IS PERFORMING AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT INSTRUMENT ERRONEOUSLY DISPLAYED PT A'S LAST NAME AND PT ID WHEN THEY SCANNED A BARCODE OF PT B. CUSTOMER INDICATED THAT PT SAMPLE WAS ONLY BEING RUN TO IDENTIFY CRITICAL RESULTS. CUSTOMER ALSO INDICATED THAT THEY NOTICED THE PROBLEM AND PROPERLY EDITED THE RESULTS. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610395 RAPIDPOINT 405 RAPIDPOINT 405 GKR SIEMENS HEALTHCARE DIAGNOSITCS

    Patients

    Seq Age Sex Outcome Treatment
    1