MalfunctionCGA
ACCU-CHEK ® INSTANT
Received Dec 10, 2024 · Event occurred Dec 2, 2024
Report 3011393376-2024-02484 · MDR key 20898207
Device
Generic name
Blood Glucose Monitoring Test Strips
Manufacturer
Roche Diabetes Care, Inc.Catalog number
07819382020
Lot number
NA
Product problems
- Imprecise or Erratic Results
- Imprecise or Erratic Results
Patient
NA · Male
- Hyperglycemia
- Hyperglycemia
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: 82 MG/DL AND 145 MG/DL. THE RESULT FROM CUSTOMER LOGBOOK HISTORY (THE DATE WAS NOT SPECIFIED BY CUSTOMER) WITHIN 15 MINUTES: 145 MG/DL AND 327 MG/DL.