LINGO GLUCOSE SYSTEM
Received Jun 19, 2026 · Event occurred May 11, 2026
Report 2954323-2026-138857 · MDR key 25564301
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Pain
- Skin Infection
- Swelling/ Edema
Narrative
Additional Manufacturer Narrative
THE REPORTED PRODUCT IS NOT EXPECTED TO BE RETURNED AS THE CUSTOMER DECLINED TO RETURN THE DEVICE. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION ACTIVITIES OR IF ADDITIONAL INFORMATION IS OBTAINED.
Description of Event or Problem
AN ADVERSE SKIN REACTION WAS REPORTED WITH WEAR OF THE ABBOTT DIABETES CARE (ADC) DEVICE. THE CUSTOMER EXPERIENCED SKIN INFECTION DESCRIBED AS SORE AND PAIN. THE CUSTOMER HAD CONTACT WITH A HEALTHCARE PROFESSIONAL, WHO TREATED THEM WITH UNSPECIFIED ANTIBIOTIC WITH LIDOCAINE AND TRIAMCINOLONE ACETONIDE OINTMENT AND KEPT THE AREA COVERED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.