MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-11-08 for T:SLIM G4 SYSTEM 9438-05 STT-GL-003 manufactured by Dexcom, Inc..
[59464354]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[59464355]
Dexcom was made aware on 10/18/2016, that on (b)(6) 2016, the device had an intermittent out of range signal. No additional event or patient information is available.
Patient Sequence No: 1, Text Type: D, B5
[60908924]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[60908965]
The complaint device was returned for evaluation. The device was visually inspected and no defect was found. Functional testing was performed and there was no failure detected. The reported event of an intermittent out of range was not confirmed. A root cause could not be determined.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004753838-2016-23086 |
| MDR Report Key | 6087933 |
| Report Source | CONSUMER |
| Date Received | 2016-11-08 |
| Date of Report | 2016-10-18 |
| Date of Event | 2016-10-08 |
| Date Mfgr Received | 2016-11-16 |
| Device Manufacturer Date | 2016-04-26 |
| Date Added to Maude | 2016-11-08 |
| 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 | KIPP DURBIN |
| Manufacturer Street | 6340 SEQUENCE DRIVE |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8582000200 |
| 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 | T:SLIM G4 SYSTEM |
| Generic Name | CONTINUOUS GLUCOSE MONITOR |
| Product Code | OIC |
| Date Received | 2016-11-08 |
| Returned To Mfg | 2016-11-11 |
| Model Number | 9438-05 |
| Catalog Number | STT-GL-003 |
| Lot Number | 5212013 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-11-08 |