LINGO GLUCOSE SYSTEM
Received Jul 21, 2026 · Event occurred Jun 21, 2026
Report 2954323-2026-172086 · MDR key 25892471
Device
Product problems
- Activation, Positioning or Separation Problem
Patient
Not reported
- Device Embedded In Tissue or Plaque
Narrative
Additional Manufacturer Narrative
PRODUCT HAS BEEN RETURNED AND IS CURRENTLY UNDERGOING INVESTIGATION PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION ACTIVITIES OR IF ADDITIONAL INFORMATION IS OBTAINED. THE DATE OF EVENT IS UNKNOWN. THE DATE ENTERED IN SECTION B3 IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.
Description of Event or Problem
THE CUSTOMER REMOVED THE ADC DEVICE AND NOTICED THAT SOMETHING WAS PROTRUDING FROM THE SENSOR. UPON CLOSER INSPECTION, THEY DETERMINED THAT THE OBJECT APPEARED TO BE THE NEEDLE. THE CUSTOMER WAS ABLE TO UNSCREW THE COMPONENT AND SUCCESSFULLY PULL THE NEEDLE OUT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.