MalfunctionCGA
ACCU-CHEK ® INSTANT
Received Dec 10, 2024 · Event occurred Nov 25, 2024
Report 3011393376-2024-02470 · MDR key 20888371
Device
Generic name
Blood Glucose Monitoring Test Strips
Manufacturer
Roche Diabetes Care, Inc.Catalog number
07819382022
Lot number
302917
Product problems
- High Test Results
- High Test Results
Patient
63 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: 520 MG/DL (USER'S METER) AND 180 MG/DL (PROFESSIONAL'S METER).
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.