MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,other report with the FDA on 2014-09-18 for V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO 40 manufactured by Valeritas, Inc..
[15997703]
It was reported to valeritas customer care during an inbound call on (b)(6) 2014 to the pt's wife who had just started on the v-go that her husband who had also been on the v-go had passed away on (b)(6) 2013. Pt was a type 2 diabetic and was on the v-go 40 for 4 months prior to passing away. She did not indicate the cause of death. Pt's wife declined to offer further info to valeritas customer care. It is unk if the v-go or diabetes was involved in this pt's death. It is not possible to assess contributory factors to this pt's death without further details and info. The adverse event assessor made multiple attempts to contact the pt's family to further investigate. Results have not been fruitful.
Patient Sequence No: 1, Text Type: D, B5
[16064299]
This mdr is being submitted following our procedure: pt expired (reportable event) while on the v-go; 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
[125152154]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226572-2014-00010 |
| MDR Report Key | 4115801 |
| Report Source | 00,OTHER |
| Date Received | 2014-09-18 |
| Date of Report | 2014-08-21 |
| Date of Event | 2013-12-02 |
| Date Mfgr Received | 2014-08-21 |
| Date Added to Maude | 2014-09-25 |
| 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 | 800 BOSTON TURNPIKE |
| Manufacturer City | SHREWSBURY MA 01545 |
| Manufacturer Country | US |
| Manufacturer Postal | 01545 |
| 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 | 2014-09-18 |
| Model Number | V-GO 40 |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| 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 S STE 100 BRIDGEWATER NJ 088072597 US 088072597 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2014-09-18 |