MalfunctionCGA
ACCU-CHEK ® INSTANT
Received Jan 28, 2025 · Event occurred Jan 17, 2025
Report 3011393376-2025-00196 · MDR key 21253201
Device
Generic name
Blood Glucose Monitoring Test Strips
Manufacturer
Roche Diabetes Care, Inc.Catalog number
07819382023
Lot number
303163
Product problems
- Imprecise or Erratic Results
- Imprecise or Erratic Results
Patient
56 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
CORRECTION - THE MANUFACTURING SITE INFORMATION WAS UPDATED IN SECTION G1.
Description of Event or Problem
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 330 MG/DL, 224 MG/DL AND 122 MG/DL.
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.