MalfunctionCGA
ACCU-CHEK ® INSTANT TEST STRIPS
Received Sep 5, 2024 · Event occurred Sep 3, 2024
Report 3011393376-2024-01872 · MDR key 20147013
Device
Product problems
- Imprecise or Erratic Results
- Imprecise or Erratic Results
Patient
52 YR · 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: 195 MG/DL, 70 MG/DL AND 130 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.