MalfunctionCGA
ACCU-CHEK ® INSTANT TEST STRIPS
Received Oct 16, 2024 · Event occurred Oct 6, 2024
Report 3011393376-2024-02154 · MDR key 20463519
Device
Generic name
Blood Glucose Monitoring Test Strips
Manufacturer
Roche Diabetes Care, Inc.Catalog number
07819382020
Lot number
302871
Product problems
- High Test Results
- High Test Results
Patient
NA · Unknown
- 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: 242 MG/DL (USER´S SYSTEM) AND 121 MG/DL (LAB RESULT). AT ANOTHER TIME ON THE SAME DAY, THE USER RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 385 MG/DL (USER´S SYSTEM) AND 145 MG/DL (LAB RESULT).