MalfunctionCGA
ACCU-CHEK ® INSTANT
Received Nov 21, 2024 · Event occurred Nov 21, 2024
Report 3011393376-2024-02357 · MDR key 20747861
Device
Generic name
Blood Glucose Monitoring Test Strips
Manufacturer
Roche Diabetes Care, Inc.Catalog number
07819382345
Lot number
302947
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: 4.3 MMOL/L AND 7.2 MMOL/L.
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.