MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-08-01 for DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM 9438-06 STT-GF-001 manufactured by Dexcom, Inc..
[115788386]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[115788387]
Dexcom was made aware on (b)(4) 2018, that on (b)(6) 2018, a pairing failure between the transmitter and smart device and/or receiver occurred. No additional patient or event information is available. Data was provided for evaluation. Data review confirmed the reported event of pairing failure. The root cause was determined to be a failed transmitter error. Reported issue of pairing failure is reportable based on the finding of transmitter failure error.
Patient Sequence No: 1, Text Type: D, B5
[136617620]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[136617621]
The complaint device was returned for evaluation. An exterior physical visual inspection was performed and the device passed. The transmitter voltage was tested and failed at 0vdc. The cloud/share data was available. Transmitter fatal error was found in share log but not related to complaint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004753838-2018-078471 |
| MDR Report Key | 7741635 |
| Report Source | CONSUMER |
| Date Received | 2018-08-01 |
| Date of Report | 2018-09-18 |
| Date of Event | 2018-06-26 |
| Date Mfgr Received | 2018-08-23 |
| Device Manufacturer Date | 2017-12-20 |
| Date Added to Maude | 2018-08-01 |
| 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 | 3 |
| Brand Name | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM |
| Generic Name | CONTINUOUS GLUCOSE MONITOR |
| Product Code | PQF |
| Date Received | 2018-08-01 |
| Returned To Mfg | 2018-07-05 |
| Model Number | 9438-06 |
| Catalog Number | STT-GF-001 |
| Lot Number | 6006057 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | DEXCOM, INC. |
| Manufacturer Address | 6340 SEQUENCE DR. SAN DIEGO CA 92121 US 92121 |
| Brand Name | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM |
| Generic Name | CONTINUOUS GLUCOSE MONITOR |
| Product Code | PFQ |
| Date Received | 2018-08-01 |
| Returned To Mfg | 2018-07-05 |
| Model Number | 9438-06 |
| Catalog Number | STT-GF-001 |
| Lot Number | 6006057 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-08-01 |