ACCU-CHEK ® INSTANT TEST STRIPS
Received Jul 10, 2024
Report 3011393376-2024-01425 · MDR key 19715672
Device
Generic name
Blood Glucose Monitoring Test Strips
Manufacturer
Roche Diabetes Care, Inc.Catalog number
07819404446
Lot number
302827
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
50 YR · Female
- Fatigue
- Headache
- Hypoglycemia
- Dizziness
- Fatigue
- Headache
- Hypoglycemia
- Dizziness
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 THAT THE PATIENT RECEIVED A BLOOD GLUCOSE TEST RESULT OF 225 MG/DL AND TOOK SOME MEDICINE TO AVOID HYPERGLYCEMIA. AFTERWARDS PATIENT WAS NOT FEELING WELL, STARTED TO HAVE HYPOGLYCEMIA SYMPTOMS OF DIZZINESS, FATIGUE, SWEATING, HYPOGLYCEMIA AND WAS ADMITTED TO HOSPITAL FOR 3 HOURS. THE PATIENT RECEIVED AN UNKNOWN TREATMENT.