MalfunctionCGA
ACCU-CHEK ® INSTANT
Received Dec 18, 2024 · Event occurred Dec 14, 2024
Report 3011393376-2024-02537 · MDR key 20964991
Device
Generic name
Blood Glucose Monitoring Test Strips
Manufacturer
Roche Diabetes Care, Inc.Catalog number
07819382020
Lot number
302875
Product problems
- Low Test Results
- Low 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.
Description of Event or Problem
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 50 MG/DL (INSTANT SYSTEM) AND 150 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.