MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-06 for DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM 9500-45 STS-OR-001 manufactured by Dexcom, Inc..
[126391637]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[126391638]
Dexcom was made aware on (b)(4) 2018, that on (b)(6) 2018, a needle retraction issue occurred. The sensor was inserted into the abdomen on (b)(6) 2018. The device has been received for investigation. A follow-up will be submitted upon completion of device investigation. No additional event or patient information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004753838-2018-136699 |
| MDR Report Key | 8043695 |
| Date Received | 2018-11-06 |
| Date of Report | 2018-10-24 |
| Date of Event | 2018-10-24 |
| Date Mfgr Received | 2018-11-17 |
| Device Manufacturer Date | 2018-07-30 |
| Date Added to Maude | 2018-11-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | MR KIPP DURBIN |
| 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 | 0 |
| Brand Name | DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM |
| Generic Name | CONTINUOUS GLUCOSE MONITOR |
| Product Code | QDK |
| Date Received | 2018-11-06 |
| Returned To Mfg | 2018-11-05 |
| Model Number | 9500-45 |
| Catalog Number | STS-OR-001 |
| Lot Number | 5240399 |
| Device Expiration Date | 2019-02-09 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | DEXCOM, INC. |
| Manufacturer Address | 6340 SEQUENCE DR. SAN DIEGO CA 92121 US 92121 |
| Brand Name | DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM |
| Generic Name | CONTINUOUS GLUCOSE MONITOR |
| Product Code | MDS |
| Date Received | 2018-11-06 |
| Returned To Mfg | 2018-11-05 |
| Model Number | 9500-45 |
| Catalog Number | STS-OR-001 |
| Lot Number | 5240399 |
| Device Expiration Date | 2019-02-09 |
| 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 DR. SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-06 |