MalfunctionCGA
ACCU-CHEK ® INSTANT TEST STRIPS
Received Jul 17, 2024 · Event occurred Jul 6, 2024
Report 3011393376-2024-01483 · MDR key 19765940
Device
Generic name
Blood Glucose Monitoring Test Strips
Manufacturer
Roche Diabetes Care, Inc.Catalog number
07819382032
Lot number
302636
Product problems
- Imprecise or Erratic Results
- Imprecise or Erratic 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: 11.3 MMOL/L (SYSTEM 1) AND 4.6 MMOL/L (SYSTEM 2). THE SAME TEST STRIP LOT NUMBER WAS USED FOR BOTH METERS AND RESULTS.