MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,study report with the FDA on 2020-03-30 for DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE S 9500-27 STS-GL-011 manufactured by Dexcom, Inc..
[186327022]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[186327023]
It was reported that the previous sensor session was continuing. No product or data was provided for investigation. Confirmation of the problem and root cause could not be determined. No injury or medical intervention was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004753838-2020-30408 |
| MDR Report Key | 9901503 |
| Report Source | HEALTH PROFESSIONAL,STUDY |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-03-04 |
| 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 | ASHLEY SPOTO |
| Manufacturer Street | 6340 SEQUENCE DRIVE |
| Manufacturer City | SAN DIEGO, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 2000200 |
| Manufacturer G1 | DEXCOM, INC. |
| Manufacturer Street | 6340 SEQUENCE DRIVE |
| Manufacturer City | SAN DIEGO, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE S |
| Generic Name | CONTINUOUS GLUCOSE MONITOR |
| Product Code | MDS |
| Date Received | 2020-03-30 |
| Model Number | 9500-27 |
| Catalog Number | STS-GL-011 |
| Lot Number | NI |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |