BEUDAMED
    FDA Adverse Event Summary report: N

    RAPIDPOINT 405

    MDR report key: 4912886 · Received July 14, 2015

    Report

    Report Number
    1217157-2015-00100
    Date Received
    July 14, 2015
    Date of Event
    June 14, 2015
    Report Date
    June 17, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    GKR
    PMA / PMN Number
    K020616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER INDICATED THAT THEY TOOK THE PRINTOUT AND LOOKED AT IT AND THE OPERATOR REALIZED HER ERROR AND WROTE THE RIGHT NAME ON THE PAPER. CUSTOMER REPORTED CORRECT RESULTS TO THE DOCTOR. CUSTOMER INDICATED THAT THEY WANTED TO FIX THE ERROR BOTH IN THE ANALYZER AND RAPIDCOMM. SIEMENS REPRESENTATIVE HAD CUSTOMER GO TO THE ANALYZER AND GO TO RECALL PATIENT AND HAD HIM HIGHLIGHT THE PATIENT ID THAT WAS ENTERED INCORRECTLY, HAD HIM TYPE IN THE CORRECT PATIENT ID AND PRESS THE GREEN ARROW. THE PATIENT NAME IS NOW CORRECT. THE ISSUE HAS BEEN RESOLVED. THE EVENT HAS OCCURRED DUE TO AN OPERATOR ERROR.

    Description of Event or Problem · 1

    CUSTOMER INDICATED THAT ON (B)(6) 2015, THEY HAD A BLOOD GAS SAMPLE THAT TYPED IN THE WRONG PATIENT ID AND THE WRONG PATIENT NAME WAS ASSIGNED TO THE SAMPLE. THE PATIENT ID TYPED IN WAS (B)(6) AND THE PATIENT NAME CAME UP AS (B)(6) AND THE CORRECT PATIENT ID WAS SUPPOSED TO BE (B)(6) AND PATIENT NAME (B)(6). CUSTOMER INDICATED THAT THE SAMPLE WAS RUN AND THE RESULTS WERE SENT TO RAPIDCOMM (DATA MANAGEMENT SYSTEM). CUSTOMER INDICATED THAT THEY WANTED TO FIX THE ERROR BOTH IN THE ANALYZER AND RAPIDCOMM. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455331 RAPIDPOINT 405 RP 405 GKR SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1