Skip to content

FDA MDR/MDV Adverse-Event Narrative

  1. Extract: event date, patient age/sex, device identifiers, reporter type.

View Source YAML

name: FDA MDR/MDV Adverse-Event Narrative
version: 0.1.0
description: '1. Extract: event date, patient age/sex, device identifiers, reporter
  type.'
metadata:
  domain: clinical
  complexity: low
  tags:
  - safety
  - fda
  - mdr
  - mdv
  - adverse-event
  requires_context: false
variables:
- name: input
  description: The primary input or query text for the prompt
  required: true
model: gpt-4
modelParameters:
  temperature: 0.2
messages:
- role: system
  content: "1. Write a concise, chronological narrative (≤ 1 200 characters) that:\n\
    \   – Describes the event circumstances and patient impact.\n   – States whether\
    \ the device malfunctioned and if it was returned.\n   – Includes any relevant\
    \ concomitant products/procedures.\n2. End with this boiler-plate sentence:\n\
    \   “This information is submitted to comply with 21 CFR 803.52.”"
- role: user
  content: '{{input}}'
testData:
- input: 'SENDER: Dr. Evelyn Vance, Chief Electrophysiologist

    DATE: 2024-06-12

    PATIENT: Patient 104-B (M/72)

    DETAILS: Pt admitted for symptomatic bradycardia. Implanted PaceMaker (SN: 998877)
    showing premature battery depletion and irregular pacing intervals. Device explanted
    on 12th. Returned to manuf? Yes. Pt stable post-op.

    '
  expected: '72-year-old male... PaceMaker (SN: 998877)... device was returned...
    This information is submitted to comply with 21 CFR 803.52.'
- input: 'REPORT: Clinical notes from RN S. Miller on 15-May-2024.

    SUBJECT: Patient 001-A failed screening (Female, 45y).

    EVENT: Severe erythema and induration at the insertion site observed during checkup.
    No device ID available in chart. Device not removed.

    '
  expected: 45-year-old female... severe erythema and induration at the insertion
    site... device not removed... This information is submitted to comply with 21
    CFR 803.52.
- input: 'TRANSCRIPT: Patient helpline call.

    CALLER: My heart thingy is beeping loudly.

    AGENT: Can I have your name, age, and device ID?

    CALLER: *click* (Caller disconnected before providing name, age, or device ID.
    Device not explanted.)

    '
  expected: Unknown age and sex... unknown device ID... device not removed... This
    information is submitted to comply with 21 CFR 803.52.
evaluators:
- name: Ends with regulatory boilerplate
  regex:
    pattern: This information is submitted to comply with 21 CFR 803\.52\.$
- name: Narrative includes patient demographics
  regex:
    pattern: (?i)(\d{1,3}-year-old (male|female)|unknown age and sex)
- name: Narrative is concise (under 1200 chars)
  python:
    code: len(output) <= 1200
- name: Mentions device return status
  regex:
    pattern: (?i)(device was returned|device not removed|device (was )?not returned|device
      return status unknown)