MalfunctionCGA
ACCU-CHEK ® INSTANT TEST STRIPS
Received Oct 11, 2024 · Event occurred Aug 5, 2024
Report 3011393376-2024-02108 · MDR key 20426734
Device
Generic name
Blood Glucose Monitoring Test Strips
Manufacturer
Roche Diabetes Care, Inc.Catalog number
07819404446
Lot number
302356
Product problems
- Imprecise or Erratic Results
- Imprecise or Erratic Results
Patient
NA · Female
- 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: 519 MG/DL, 188 MG/DL AND 126 MG/DL.
Additional Manufacturer Narrative
CORRECTION: IN D4 THE LOT NUMBER INFORMATION WAS UPDATED.