MalfunctionCGA
ACCU-CHEK ® INSTANT
Received Nov 21, 2024 · Event occurred Nov 15, 2024
Report 3011393376-2024-02355 · MDR key 20747564
Device
Generic name
Blood Glucose Monitoring Test Strips
Manufacturer
Roche Diabetes Care, Inc.Catalog number
07819374044
Lot number
302885
Product problems
- Imprecise or Erratic Results
- Imprecise or Erratic Results
Patient
75 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
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: 400 MG/DL AND 190 MG/DL.