MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-24 for DEXCOM G6 GLUCOSE PROGRAM CONTINUOUS GLUCOSE MONITORING SYSTEM N/A SW11786 manufactured by Dexcom, Inc..
[176279841]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[176279842]
It was reported that signal loss over one hour occurred. It was determined that the signal loss was related to the mobile application. A review of the share logs was performed and signal loss was found within the investigation window. The allegation was confirmed. The probable cause was the transmitter and app were unable to establish a connection. No injury or medical intervention was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004753838-2020-07654 |
| MDR Report Key | 9628237 |
| Report Source | CONSUMER |
| Date Received | 2020-01-24 |
| Date of Report | 2020-01-24 |
| Date of Event | 2019-12-31 |
| Date Mfgr Received | 2019-12-31 |
| Date Added to Maude | 2020-01-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS ASHLEY SPOTO |
| Manufacturer Street | 6340 SEQUENCE DR. |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8582000200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEXCOM G6 GLUCOSE PROGRAM CONTINUOUS GLUCOSE MONITORING SYSTEM |
| Generic Name | CONTINUOUS GLUCOSE MONITOR |
| Product Code | QDK |
| Date Received | 2020-01-24 |
| Model Number | N/A |
| Catalog Number | SW11786 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEXCOM, INC. |
| Manufacturer Address | 6340 SEQUENCE DR. SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-24 |