MalfunctionCGA
ACCU-CHEK ® INSTANT
Received Dec 6, 2024 · Event occurred Oct 18, 2024
Report 3011393376-2024-02452 · MDR key 20865093
Device
Generic name
Blood Glucose Monitoring Test Strips
Manufacturer
Roche Diabetes Care, Inc.Catalog number
07819366587
Lot number
302293
Product problems
- High Test Results
- High Test Results
Patient
39 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 430 MG/DL (SYSTEM 1) AND 120 MG/DL (SYSTEM 2).
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. THIS CASE, WITH PATIENT IDENTIFIER CN-(B)(6) (SYSTEM 1), IS RELATED TO CASE WITH PATIENT IDENTIFIER C(B)(6) (SYSTEM 2).