MalfunctionCGA
ACCU-CHEK ® INSTANT
Received Jan 24, 2025 · Event occurred Jan 20, 2025
Report 3011393376-2025-00154 · MDR key 21230225
Device
Generic name
Blood Glucose Monitoring Test Strips
Manufacturer
Roche Diabetes Care, Inc.Catalog number
07819374044
Lot number
302721
Product problems
- High Test Results
- High Test Results
Patient
69 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE EVENT OCCURRED OUTSIDE OF THE UNITED STATES. WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES.
Description of Event or Problem
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 102 MG/DL (USER´S METER) AND 246 MG/DL (LAB RESULT).
Additional Manufacturer Narrative
IN CHAPTER G1 THE MANUFACTURER INFORMATION WAS UPDATED.