ACCU-CHEK ® INSTANT TEST STRIPS
Received Aug 27, 2024
Report 3011393376-2024-01798 · MDR key 20075168
Device
Generic name
Blood Glucose Monitoring Test Strips
Manufacturer
Roche Diabetes Care, Inc.Catalog number
07819404446
Lot number
302825
Product problems
- High Test Results
- High Test Results
Patient
NA · Female
- Loss of consciousness
- Loss of consciousness
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 TOOK INSULIN BASED ON THE RESULT OF 500 MG/DL AND FAINTED AFTERWARDS. SHE WAS ADMITTED TO HOSPITAL 30 MINUTES LATER AND STAYED THERE FOR FIVE HOURS. THE RESULT TAKEN UPON ARRIVAL AT THE HOSPITAL WAS 270 MG/DL. IT WAS NOT REPORTED IF OR WHICH TREATMENT THE CUSTOMER RECEIVED AT THE HOSPITAL. THE CUSTOMER BELIEVES THAT THE READINGS OF HER SYSTEM ARE TOO HIGH AS SHE FAINTED AFTER TAKING INSULIN BASED ON THE RESULT RECEIVED.