MalfunctionCGA
ACCU-CHEK ® INSTANT
Received Dec 6, 2024 · Event occurred Nov 29, 2024
Report 3011393376-2024-02450 · MDR key 20864809
Device
Generic name
Blood Glucose Monitoring Test Strips
Manufacturer
Roche Diabetes Care, Inc.Catalog number
07819382022
Lot number
302915
Product problems
- High Test Results
- High Test Results
Patient
64 YR · Male
- Hypoglycemia
- Hypoglycemia
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: 134 MG/DL, 208 MG/DL, 222 MG/DL, AND 299 MG/DL. THE PATIENT EXPERIENCED HYPOGLYCEMIA SYMPTOMS.