Stelo CGM
Received Jul 18, 2026 · Event occurred Jul 17, 2026
Report MW6000094 · MDR key 50068846
Device
Generic name
Integrated Continuous Glucose Monitor For Non-intensive Glucose Monitoring, Over-the-counter
Product problems
- Computer Software Problem
- No Device Output
- Wireless Communication Problem
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
Stelo CGM not pairing with iPhone 14 Pro Max. I have had several issues with earlytermination of the product and not pairing to Bluetooth on Apple IPhone 14 Pro Max.With the early termination of monitoring, the Stelo app request buying a new monitor. Ihave had 5 CGMs not pair and have received replacements of 2 CGMs after filing cases.2 of the cases were approved. I have had to send emails and chat with stelobot forcommunication. I did try to speak with a rep with Dexcom and was told that the rep wasnot educated on how the Stelo monitor works which is concerning since Dexcomproduces the Stelo and it is similar to Dexcom7. PT: 4582. DEVICE: 3283, 1435, 1112. This report captures Stelo CGM #5. Reference Reports:CDRH-50068612, CDRH-50068667, CDRH-50068738, CDRH-50068788.