ACCU-CHEK ® INSTANT TEST STRIPS
Received Sep 20, 2024 · Event occurred Jul 23, 2024
Report 3011393376-2024-01974 · MDR key 20268652
Device
Generic name
Blood Glucose Monitoring Test Strips
Manufacturer
Roche Diabetes Care, Inc.Catalog number
07819404020
Lot number
302366
Product problems
- High Test Results
- High Test Results
Patient
NA · 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: 321 MG/DL (PATIENT'S METER) AND 140 MG/DL (LAB RESULT).
Additional Manufacturer Narrative
CORRECTION - THE CATALOG AND UNIQUE IDENTIFIER NUMBERS WERE UPDATED IN SECTION D4 BASED ON THE RETURNED PRODUCT. THE CUSTOMER RETURNED AN EMPTY TEST STRIP VIAL. THEREFORE, THE ACTUAL TEST STRIPS WERE NOT AVAILABLE FOR EVALUATION.