STELO GLUCOSE BIOSENSOR SYSTEM
Received Jun 11, 2026 · Event occurred May 27, 2026
Report 3004753838-2026-171871 · MDR key 25479893
Device
Generic name
Continuous Glucose Monitor
Manufacturer
Dexcom, Inc.Model number
9500-174Catalog number
STP-XN-001
Lot number
1825268001
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
34 YR · Unknown
- Erythema
- Hypersensitivity/Allergic reaction
- Itching Sensation
- Pain
- Rash
Narrative
Additional Manufacturer Narrative
(B)(4). LABELING INDICATES: INSERTING THE SENSOR AND WEARING THE ADHESIVE PATCH MIGHT CAUSE INFECTION, BLEEDING, PAIN OR SKIN IRRITATIONS (E.G. REDNESS, SWELLING, BRUISING, ITCHING, SCARRING OR SKIN DISCOLORATION).
Description of Event or Problem
IT WAS REPORTED VIA STELOBOT THAT A SKIN REACTION WAS OCCURRED. THE BIOSENSOR WAS INSERTED IN THE ARM ON (B)(6) 2026. ON (B)(6) 2026 SYMPTOMS INCLUDED A RASH WITH REDNESS, INFLAMMATION, AND WATERY DRAINAGE WHICH SHE ATTRIBUTED TO THE SENSOR AND OVERPATCH. SHE HAD ITCHING, BURNING AND PAIN SENSATIONS IN THE AREA. SHE RECEIVED TREATMENT ON (B)(6) 2026 FROM AN UNSPECIFIED HEALTHCARE PROVIDER (HCP) WITH ORAL AND IV PRESCRIPTION MEDICATIONS (DEXAMETHASONE, DIPHENHYDRAMINE, FAMOTIDINE (PEPCID) AND AN EPI PEN. NO DATA OR PRODUCT WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL CUSTOMER OR EVENT INFORMATION IS AVAILABLE.