MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,consumer report with the FDA on 2014-10-23 for V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO 40 manufactured by Valeritas, Inc.
[4982145]
It was reported to valeritas customer care by type 2 diabetic pt that he had experienced hypoglycemic events with the lowest blood glucose reading of 17 while using the v-go. Pt has been using v-go therapy for one year. Hcp has changed the pt from v-go 30 to v-go 40. Pt stated that there were times of low bg readings where he self medicated by eating peanut butter, milk, and orange juice. Pt also stated "he has had low readings of 17-24-25-27-33 and he said when it was 17 and 24 his wife called 911 and he came aware when he was in an ambulance with "police around him". Pt has also stated that his hcp is aware of these incidents. Valeritas ae assessors have tried to contact the pt to investigate further, without success. Valeritas product compliance has sent a letter to the pt requesting contact info, via (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[12392095]
This mdr is being submitted following our procedure: pt reported hypoglycemic event with bg reading as low as 17 which required third party intervention to treat; device unavailable for investigation; insufficient info available to explain if v-go contributed to the event or not.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226572-2014-00014 |
| MDR Report Key | 4203707 |
| Report Source | 04,CONSUMER |
| Date Received | 2014-10-23 |
| Date of Report | 2014-10-07 |
| Date of Event | 2014-10-07 |
| Date Mfgr Received | 2014-10-07 |
| Date Added to Maude | 2014-10-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 | SCOTT HUIE |
| Manufacturer Street | 750 ROUTE 202S SUITE 600 |
| Manufacturer City | BRIDGEWATER NJ 08807 |
| Manufacturer Country | US |
| Manufacturer Postal | 08807 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | V-GO DISPOSABLE INSULIN DELIVERY DEVICE |
| Generic Name | V-GO |
| Product Code | KZE |
| Date Received | 2014-10-23 |
| Model Number | V-GO 40 |
| Lot Number | VG313022 |
| Device Expiration Date | 2016-03-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VALERITAS, INC |
| Manufacturer Address | 750 ROUTE 202 SOUTH, SUITE 100 BRIDGEWATER NJ 088072597 US 088072597 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2014-10-23 |