MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-30 for DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM 9438-06 STT-GF-005 manufactured by Dexcom, Inc..
[185565373]
No product was returned for evaluation. Should new relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[185565374]
It was reported that the customer received intermittent invalid transmitter id alerts. Despite multiple attempts, a sensor session was unable to be started. No additional patient or event information was available. A root cause could not be determined. A replacement transmitter was sent to the
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3013756811-2020-29235 |
| MDR Report Key | 9898386 |
| Report Source | CONSUMER |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-07 |
| Date Mfgr Received | 2020-03-07 |
| Date Added to Maude | 2020-03-30 |
| 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 | MICK TRIER |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8584011451 |
| Manufacturer G1 | DEXCOM, INC. |
| Manufacturer Street | 6340 SEQUENCE DRIVE |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92121 |
| 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 | SENSOR, GLUCOSE, INVASIVE |
| Product Code | MDS |
| Date Received | 2020-03-30 |
| Model Number | 9438-06 |
| Catalog Number | STT-GF-005 |
| 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 DRIVE SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |