MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-22 for DEXCOM G6 CONTINUOUS GLUCOSE MONITOR manufactured by Dexcom, Inc..
[176435954]
Dexcom g6 continuous glucose monitor insertion device failed. The insertion tool failed to retract the needle upon pressing the insertion button. The needle was stuck under the skin (but also attached to the skin with adhesive). Had to use a large wooden spoon to whack the back of the insertion device very hard several times in order to get the needle to retract from skin. This happened three times with three different sensors from the same lot number. It was very painful and if we had heard about others who had the same issue using the? Wooden spoon trick? , we likely would have to peel the sensor off while the needle was still stuck in her skin, resulting in more bleeding. This problem has affected many users. Many users are now including wooden spoons in their children? S? Emergency diabetes kits? Along with their g6 sensors in case it happens at school or on the road. My daughter worries every time we change sensors that they will get stuck again. This should not be a concern we deal with? The product should work properly every time. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092457 |
| MDR Report Key | 9622874 |
| Date Received | 2020-01-22 |
| Date of Report | 2020-01-18 |
| Date of Event | 2020-01-11 |
| Date Added to Maude | 2020-01-23 |
| 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 FAMILY MEMBER OR FRIEND |
| 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 | 3 |
| Brand Name | DEXCOM G6 CONTINUOUS GLUCOSE MONITOR |
| Generic Name | INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM FOR NON-INTENSE DIABETES MANAGEM |
| Product Code | QDK |
| Date Received | 2020-01-22 |
| Model Number | G6 |
| Lot Number | 7266524 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEXCOM, INC. |
| Brand Name | DEXCOM G6 CONTINUOUS GLUCOSE MONITOR |
| Generic Name | INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM FOR NON-INTENSE DIABETES MANAGEM |
| Product Code | QDK |
| Date Received | 2020-01-22 |
| Model Number | G6 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | DEXCOM, INC. |
| Brand Name | DEXCOM G6 CONTINUOUS GLUCOSE MONITOR |
| Generic Name | INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM FOR NON-INTENSE DIABETES MANAGEM |
| Product Code | QDK |
| Date Received | 2020-01-22 |
| Model Number | G6 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | DEXCOM, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-22 |