MalfunctionCGA
ACCU-CHEK ® INSTANT
Received Dec 12, 2024 · Event occurred Dec 3, 2024
Report 3011393376-2024-02496 · MDR key 20913088
Device
Generic name
Blood Glucose Monitoring Test Strips
Manufacturer
Roche Diabetes Care, Inc.Catalog number
07819382020
Lot number
303162
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
CORRECTION - THE MANUFACTURING SITE INFORMATION WAS UPDATED IN SECTION G1.
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: 350 MG/DL (INSTANT SYSTEM) AND 145 MG/DL (LABORATORY DEVICE).