MalfunctionCGA
ACCU-CHEK ® INSTANT
Received Nov 25, 2024 · Event occurred Nov 18, 2024
Report 3011393376-2024-02363 · MDR key 20771217
Device
Generic name
Blood Glucose Monitoring Test Strips
Manufacturer
Roche Diabetes Care, Inc.Catalog number
07819374032
Lot number
303201
Product problems
- High Test Results
- High Test Results
Patient
NA · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 6.1 MMOL/L WITH THE INSTANT STRIPS AND 3.1 MMOL/L, RESULT OBTAINED WITH FASTING VENOUS BLOOD.
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.