MalfunctionCGA
ACCU-CHEK ® INSTANT TEST STRIPS
Received Oct 3, 2024
Report 3011393376-2024-02053 · MDR key 20364640
Device
Product problems
- High Test Results
- High Test Results
Patient
25 YR · Female
- 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. THIS CASE, WITH PATIENT IDENTIFIER CN-494802B (SYSTEM 2), IS RELATED TO CASE WITH PATIENT IDENTIFIER (B)(4) (SYSTEM 1).
Description of Event or Problem
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 285 MG/DL (SYSTEM 1) AND 110 MG/DL (SYSTEM 2).