MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-16 for DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM N/A SW10611 manufactured by Dexcom, Inc..
[97919579]
The patient experienced adverse events on different days with the same device. The following reports are being submitted: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[97919580]
Dexcom was made aware on (b)(4) 2017 that on (b)(6) 2017, a loss of connection between the transmitter and smart device occurred. No additional patient or event information is available. Data was returned and evaluated. The reported event of a loss of connection was confirmed via data. A root cause could not be determined.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004753838-2018-005655 |
| MDR Report Key | 7195674 |
| Date Received | 2018-01-16 |
| Date of Report | 2017-12-21 |
| Date of Event | 2017-12-09 |
| Date Mfgr Received | 2017-12-21 |
| Date Added to Maude | 2018-01-16 |
| 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 | MR KIPP DURBIN |
| 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 | 0 |
| Brand Name | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM |
| Generic Name | CONTINUOUS GLUCOSE MONITOR |
| Product Code | PQM |
| Date Received | 2018-01-16 |
| Model Number | N/A |
| Catalog Number | SW10611 |
| 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 | 2018-01-16 |