MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,consumer report with the FDA on 2014-02-21 for V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO 40 manufactured by Valeritas, Llc.
[21110829]
Patient on v-gu 40 called into the company's customer (b)(4) to report multiple adverse events while wearing v-go. Patient reports that he is a type 2 diabetic and has been on v-go for approximately 3 months. The patient reported that he wears two v-go 40's every 12 hours (off label use). Patient reports: skin irritation, hyperglycemia, laser surgery to correct "diabetic glaucoma. " patient reports a "pre-v-go" blood glucose range of 120-150 and a "with v-go" blood glucose range of 82-400. Patient reports that he had outpatient surgery for diabetic glaucoma correction for his left and right eyes. Patient believes that the glaucoma may be related to hyperglycemia and blood glucose variability while wearing v-go.
Patient Sequence No: 1, Text Type: D, B5
[21168173]
The devices were not returned for investigation, so unable to confirm any device malfunction. Patient was using two v-go's at the same time (off label usage) which indicates a large insulin requirement and therefore prone to hyperglycemia. Patient reports wide variation in bg levels when using the device. Chronic hyperglycemia can cause an increase in ocular pressure (glaucoma) which, if left untreated, can lead to blindness (serious injury). In this case, the patient required medical treatment (laser surgery). Since the patient required medical intervention (laser surgery) for treatment of a potentially serious adverse event and there was no attributable cause (due to device not being returned) a mdr is being submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226572-2014-00001 |
| MDR Report Key | 3641092 |
| Report Source | 04,CONSUMER |
| Date Received | 2014-02-21 |
| Date of Report | 2014-01-22 |
| Date of Event | 2014-01-08 |
| Date Mfgr Received | 2014-01-22 |
| Date Added to Maude | 2014-02-25 |
| 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 | 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 | 2014-02-21 |
| Model Number | V-GO 40 |
| Lot Number | UNK |
| 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, LLC |
| Manufacturer Address | 750 ROUTE 202 SOUTH, SUITE 100 BRIDGEWATER NJ 088072597 US 088072597 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention; 2. Deathisabilit | 2014-02-21 |