MalfunctionCGA
ACCU-CHEK ® INSTANT
Received Jan 7, 2025 · Event occurred Dec 30, 2024
Report 3011393376-2025-00057 · MDR key 21093543
Device
Generic name
Blood Glucose Monitoring Test Strips
Manufacturer
Roche Diabetes Care, Inc.Catalog number
07819404446
Lot number
303266
Product problems
- Imprecise or Erratic Results
- Imprecise or Erratic Results
Patient
65 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
CORRECTION - G1 - MFG SITE ESTABLISHMENT NAME AND ADDRESS.
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: 300 MG/DL AND 140 MG/DL.