MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-31 for DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM 9438-06 STT-GF-001 manufactured by Dexcom, Inc..
[185721733]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[185721734]
It was reported that there were no calibration prompts. The complaint device has been received for device investigation. A follow-up report will be submitted upon completion of device investigation.
Patient Sequence No: 1, Text Type: D, B5
[188147371]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[188147372]
The complaint transmitter was returned for evaluation. The device was visually inspected and no defect was found. The device passed a voltage test. Pairing with nordic bluetooth device: passed. The share log was reviewed and could not confirm the complaint. The probable cause could not be determined via product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004753838-2020-030637 |
| MDR Report Key | 9903486 |
| Report Source | CONSUMER |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2019-12-17 |
| Date Added to Maude | 2020-03-31 |
| 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 G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM |
| Generic Name | CONTINUOUS GLUCOSE MONITOR |
| Product Code | PQF |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2020-03-31 |
| Model Number | 9438-06 |
| Catalog Number | STT-GF-001 |
| Lot Number | 7267300 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| 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 | 2020-03-31 |