MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-29 for EVERSENSE TRANSMITTER 102208-500 FG-3300-01-001 manufactured by Senseonics Inc..
[185491967]
The patient was unconscious and ambulance was called in but not hospitalized. She was given glucose by a shot. Patient was doing much better. Since the patient was unconscious she was not aware of the device being alerted. Hence, no further investigation is required.
Patient Sequence No: 1, Text Type: N, H10
[185491968]
On (b)(6) 2019, senseonics was made aware of an adverse event where the patient could not recall whether she received the alerts on her device because she was unconscious. The ambulance was called in but she was not hospitalized.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009862700-2020-00389 |
| MDR Report Key | 9896159 |
| Report Source | CONSUMER |
| Date Received | 2020-03-29 |
| Date of Report | 2020-02-28 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2019-04-08 |
| Date Added to Maude | 2020-03-29 |
| 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. VALLIKANNU SOMASUNDARAM |
| Manufacturer Street | 20451 SENECA MEADOWS PARKWAY |
| Manufacturer City | GERMANTOWN, MD |
| Manufacturer Country | US |
| Manufacturer G1 | SENSEONICS INC. |
| Manufacturer Street | 20451 SENECA MEADOWS PARKWAY |
| Manufacturer City | GERMANTOWN,, MD |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EVERSENSE TRANSMITTER |
| Generic Name | CONTINUOUS GLUCOSE MONITORING SYSTEM |
| Product Code | QCD |
| Date Received | 2020-03-29 |
| Model Number | 102208-500 |
| Catalog Number | FG-3300-01-001 |
| Lot Number | 113071 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SENSEONICS INC. |
| Manufacturer Address | 20451 SENECA MEADOWS PARKWAY GERMANTOWN,, MD US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-29 |