MalfunctionCGA
ACCU-CHEK ® INSTANT TEST STRIPS
Received Aug 22, 2024 · Event occurred Aug 5, 2024
Report 3011393376-2024-01763 · MDR key 20040504
Device
Generic name
Blood Glucose Monitoring Test Strips
Manufacturer
Roche Diabetes Care, Inc.Catalog number
07819366020
Lot number
ASKU
Product problems
- High Test Results
- High Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
UPDATE H8 - USAGE OF DEVICE CORRECTED.
Description of Event or Problem
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 315 MG/DL (USER'S ACCU-CHEK INSTANT SYSTEM) AND 150 MG/DL (UNKNOWN PROFISSIONAL METER).
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.