MalfunctionCGA
ACCU-CHEK ® INSTANT TEST STRIPS
Received Sep 26, 2024 · Event occurred Sep 24, 2024
Report 3011393376-2024-02005 · MDR key 20315359
Device
Generic name
Blood Glucose Monitoring Test Strips
Manufacturer
Roche Diabetes Care, Inc.Catalog number
07819404020
Lot number
302900
Product problems
- Low Test Results
- Low 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: 73 MG/DL (PATIENT METER) AND 205 MG/DL (PROFESSIONAL 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.