BEUDAMED
    FDA Adverse Event Other Summary report: N

    CARESUITE ED PULSECHECK

    MDR report key: 1750829 · Received July 7, 2010

    Report

    Report Number
    3005244943-2010-00004
    Event Type
    Other
    Date Received
    July 7, 2010
    Report Date
    June 2, 2010
    Manufacturer
    PICIS INC.
    Product Code
    NSX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OUR INVESTIGATION FOUND THAT THE REASON FOR NO ALLERGY INTERACTION NOTIFICATION WAS A RESULT OF ALLERGIES CODED USING A NON-SUPPORTED EXTERNAL DRUG DATABASE SCHEMA BEING SENT TO ED PULSECHECK FROM THE ENTERPRISE INFO SYSTEM. PICIS IS WORKING WITH THE CUSTOMER TO REVIEW ALLERGY CODES SENT PRIOR TO JUNE 2010 TO ASCERTAIN IF THERE ARE ANY ADDITIONAL ERRONEOUS ALLERGY CODES STORED IN THE DATABASE. ADDITIONALLY, DURING THE COURSE OF OUR INVESTIGATION WE HAVE IDENTIFIED THREE SIMILAR CUSTOMER SITE CONFIGURATIONS WITH DISPARATE DRUG DATABASES. OF THESE SITES, TWO HAVE REPORTED THIS CONCERN TO PICIS, ONE OF WHICH HAS BEEN SUBMITTED IN AN EARLIER REPORT. WE ARE WORKING WITH EACH OF THESE CUSTOMERS TO PREVENT UNSUPPORTED ALLERGY CODES FROM BEING SENT TO THE PICIS APPLICATION. PICIS IS ALSO EXPLORING THE POTENTIAL FOR SIMILAR SYSTEM ADMINISTRATION ERROR IN OTHER SITES. WE WILL EVALUATE THE NEED FOR CORRECTIVE ACTION AND IMPLEMENT ACCORDINGLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A NEAR PT INCIDENT INVOLVING PICIS' ED (EMERGENCY DEPT.) ELECTRONIC HEALTH RECORD APPLICATION RELATED TO ALLERGY DATA RECEIVED VIA INTERFACE FROM THE CUSTOMER'S ENTERPRISE INFO SYSTEM, WHICH WAS 'CODED' USING A 3RD PARTY DRUG DATABASE TERMINOLOGY NOT SUPPORTED BY PICIS. THE NUMERIC CODE REPRESENTING 'CEFTRIAXONE' IN THE ENTERPRISE SYSTEM REPRESENTED A DIFFERENT ALLERGY CONCEPT IN THE PICIS' SUPPORTED THIRD PARTY DRUG DATABASE. THE SCREEN DISPLAYED THE CORRECT ALLERGY NAME OF CEFTRIAXONE TO THE PHYSICIAN, BUT THE BACKGROUND ALLERGY CHECKING LOGIC (DETERMINED BY THE NUMERIC CODE SENT FROM THE INTERFACE) DID NOT NOTIFY THE PHYSICIAN OF A POTENTIAL ALLERGY INTERACTION, WHEN A MEDICATION ORDER FOR ROCEPHIN WAS WRITTEN. THE PT WAS GIVEN THE MEDICATION WHILE IN THE ED. THE PT DID NOT HAVE ANY ADVERSE REACTION TO THE MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARESUITE ED PULSECHECK S/W, TRANSMISSION & STORAGE PATIENT DATA NSX PICIS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI SUPPORTED DRUG DATABASE - MICROMEDEX.| CUSTOMER THIRD PARTY HIS CPSI AND A NON-PICIS