MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-07 for DEXCOM G6 CONTINUOUS GLUCOSE MONITOR 9500-45 manufactured by Dexcom Inc..
[132568033]
I have recently started wearing the dexcom g6 continuous glucose monitor and noticed that its adhesive qualities are incredibly poor. It is supposed to be worn for 10 calendar days. However, the quality of the adhesion is so pathetically poor that it can barely make a 5 day wear mark. With the outrageous cost for insulin supplies and that fact that this product's ability to stay stuck in the skin is so poor, it's very concerning since the fda gave it a stamp of approval.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5082936 |
| MDR Report Key | 8228286 |
| Date Received | 2019-01-07 |
| Date of Report | 2019-01-04 |
| Date of Event | 2019-01-04 |
| Date Added to Maude | 2019-01-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 CONTINUOUS GLUCOSE MONITOR |
| Generic Name | INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM FACTORY CALIBRATED |
| Product Code | QDK |
| Date Received | 2019-01-07 |
| Model Number | G6 |
| Catalog Number | 9500-45 |
| Lot Number | 5247402 |
| Device Expiration Date | 2019-10-16 |
| Operator | LAY USER/PATIENT |
| 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 | 2019-01-07 |