MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-03 for DEXCOM CONTINUOUS GLUCOSE MONITOR manufactured by Dexcom.
[46775264]
Mother of pt reports she was routinely changing his continuous glucose monitor about a week and a half ago and noticed that when she removed the unit, the thin sensor wires that are injected into the fatty tissue were not present. Moc placed a new cgm on the other side (left) of his abdomen, immediately received a "failure" signal and removed it. Again, no wires present upon removal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5062714 |
| MDR Report Key | 5705329 |
| Date Received | 2016-06-03 |
| Date of Report | 2016-06-03 |
| Date of Event | 2016-05-15 |
| Date Added to Maude | 2016-06-08 |
| 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 |
| 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 CONTINUOUS GLUCOSE MONITOR |
| Generic Name | DEXCOM CONTINUOUS GLUCOSE MONITOR |
| Product Code | PJT |
| Date Received | 2016-06-03 |
| Lot Number | 5205382 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEXCOM |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-06-03 |