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..
[187420591]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[187420592]
It was reported that signal loss over one hour occurred. A review of the share logs was performed and a loss of connection was found within the investigation window. However, the device operated within specification. The allegation was not confirmed. The probable cause could not be determined. No injury or medical intervention was reported.
Patient Sequence No: 1, Text Type: D, B5
[188147467]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[188147468]
It was reported that signal loss over one hour occurred. The product was evaluated. An external/exterior visual inspection was performed and passed. Voltage check was performed and passed (0. 21 vdc). Pairing with (b)(4) bluetooth device was performed and passed. A review of the share logs was performed and signal loss was found within the investigation window. However, the device operated within specification. The allegation was not confirmed. The probable cause could not be determined. No injury or medical intervention was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004753838-2020-030743 |
| MDR Report Key | 9903899 |
| Report Source | CONSUMER |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-09 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2019-07-28 |
| 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 |
| Model Number | 9438-06 |
| Catalog Number | STT-GF-001 |
| Lot Number | 7258569 |
| 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 | 2020-03-31 |