MalfunctionCGA
ACCU-CHEK ® INSTANT TEST STRIPS
Received Nov 22, 2024 · Event occurred Nov 13, 2024
Report 3011393376-2024-02362 · MDR key 20763571
Device
Generic name
Blood Glucose Monitoring Test Strips
Manufacturer
Roche Diabetes Care, Inc.Catalog number
07819404446
Lot number
303264
Product problems
- Imprecise or Erratic Results
- Imprecise or Erratic Results
Patient
NA · Female
- 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: 598 MG/DL (INSTANT SYSTEM) AND 120 MG/DL (PROFESSIONAL METER).
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.