ACCU-CHEK ® INSTANT TEST STRIPS
Received Oct 15, 2024 · Event occurred Oct 8, 2024
Report 3011393376-2024-02125 · MDR key 20449063
Device
Generic name
Blood Glucose Monitoring Test Strips
Manufacturer
Roche Diabetes Care, Inc.Catalog number
07819374020
Lot number
302801
Product problems
- High Test Results
- High Test Results
Patient
NA · Unknown
- Hypoglycemia
- Shaking/Tremors
- Hypoglycemia
- Shaking/Tremors
Narrative
Description of Event or Problem
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 117 MG/DL WITH THE INSTANT SYSTEM AND 68 MG/DL WITH A PROFESSIONAL'S DEVICE ON (B)(6) 2024, AS WELL AS 108 MG/DL WITH THE INSTANT SYSTEM AND 60 MG/DL WITH A PROFESSIONAL'S DEVICE ON (B)(6) 2024. THE CUSTOMER ALLEGED SYMPTOMS LIKE TREMBLING, GIDDINESS, PALPATION.
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.