MalfunctionCGA
ACCU-CHEK ® INSTANT TEST STRIPS
Received Aug 22, 2024
Report 3011393376-2024-01686 · MDR key 20038595
Device
Generic name
Blood Glucose Monitoring Test Strips
Manufacturer
Roche Diabetes Care, Inc.Catalog number
07819404049
Lot number
302513
Product problems
- Imprecise or Erratic Results
- Imprecise or Erratic Results
Patient
NA · 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: 85 MG/DL (SYSTEM 1) AND 165 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 (B)(6) (SYSTEM 1), IS RELATED TO CASE WITH PATIENT IDENTIFIER (B)(6) (SYSTEM 2).