MalfunctionCGA
ACCU-CHEK ® INSTANT TEST STRIPS
Received Aug 22, 2024 · Event occurred Jul 25, 2024
Report 3011393376-2024-01689 · MDR key 20042827
Device
Generic name
Blood Glucose Monitoring Test Strips
Manufacturer
Roche Diabetes Care, Inc.Catalog number
06454011023
Lot number
301662
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: 205 MG/DL (SYSTEM 1) AND 108 MG/DL (SYSTEM 2). THE SAME TEST STRIP LOT NUMBER WAS USED FOR BOTH METERS AND RESULTS.
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.