MalfunctionCGA
ACCU-CHEK ® INSTANT TEST STRIPS
Received Aug 7, 2024 · Event occurred Jul 18, 2024
Report 3011393376-2024-01665 · MDR key 19927812
Device
Product problems
- Imprecise or Erratic Results
- Imprecise or Erratic Results
Patient
60 YR · Unknown
- Hypoglycemia
- Hypoglycemia
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 THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 114 MG/DL (INSTANT SYSTEM) AND 67 MG/DL (ACTIVE SYSTEM). THE CUSTOMER EXPERIENCED HEADACHES AND FELT UNWELL.