MalfunctionCGA
ACCU-CHEK ® INSTANT
Received Nov 28, 2024
Report 3011393376-2024-02406 · MDR key 20804168
Device
Generic name
Blood Glucose Monitoring Test Strips
Manufacturer
Roche Diabetes Care, Inc.Catalog number
07819366580
Lot number
302523
Product problems
- High Test Results
- High Test Results
Patient
76 YR · 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: 8,4 MMOL/L (PATIENT'S METER) AND 4,4 MMOL/L (LAB RESULT).