MalfunctionCGA
ACCU-CHEK ® INSTANT
Received Feb 10, 2025 · Event occurred Feb 6, 2025
Report 3011393376-2025-00252 · MDR key 21345170
Device
Product problems
- Imprecise or Erratic Results
- Imprecise or Erratic Results
Patient
70 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
UPDATE SECTION G1: MANUFACTURE SITE DATA CORRECTED.
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: 132 MG/DL AND 300 MG/DL.