MalfunctionCGA
ACCU-CHEK ® INSTANT TEST STRIPS
Received Aug 5, 2024 · Event occurred Aug 2, 2024
Report 3011393376-2024-01633 · MDR key 19905650
Device
Generic name
Blood Glucose Monitoring Test Strips
Manufacturer
Roche Diabetes Care, Inc.Catalog number
07819382020
Lot number
302937
Product problems
- High Test Results
- High Test Results
Patient
NA · Unknown
- 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: 130 MG/DL WITH THE INSTANT SYSTEM AND 70 MG/DL WITH A LABORATORY DEVICE.
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.