MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-18 for DEXCOM G6 manufactured by Dexcom Inc..
[139292606]
Dexcom g6 doesn't work as advertised. Bg readings are well outside the acceptable range. Sensor patch falls off within 3-4 days of being applied. Sensor patches generally are wrinkled or damaged during the application process. This product is cheap and is a danger to t1d in the usa.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084988 |
| MDR Report Key | 8432518 |
| Date Received | 2019-03-18 |
| Date of Report | 2019-03-14 |
| Date of Event | 2019-03-14 |
| Date Added to Maude | 2019-03-19 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DEXCOM G6 |
| Generic Name | INTEGRATED CONTINUOUS GLUCOSE MONITOR SYSTEM FOR NON-INTENSIVE DIABETES MANAGEME |
| Product Code | QDK |
| Date Received | 2019-03-18 |
| Model Number | G6 |
| Lot Number | 5246926 |
| Device Expiration Date | 2019-10-11 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | DEXCOM INC. |
| Brand Name | DEXCOM G6 |
| Generic Name | INTEGRATED CONTINUOUS GLUCOSE MONITOR SYSTEM FOR NON-INTENSIVE DIABETES MANAGEME |
| Product Code | QDK |
| Date Received | 2019-03-18 |
| Model Number | G6 |
| Lot Number | 5246926 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEXCOM INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-18 |