MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,consumer report with the FDA on 2013-12-11 for V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO 20 manufactured by Valeritas, Inc..
[3972698]
Type 1 diabetic vgo 20 patient reported to valeritas customer care that she was hospitalized with dka on (b)(6) 2013 and discharged to home (b)(6) 2013. Patient reports hyperglycemia with bg ranging from 300 to 500 started (b)(6) 2013 and continued till she was hospitalized (b)(6) 2013. Patient started using vgo (b)(6) 2013. Patient reports that pre-vgo she was on lantus 20 units daily and victoza 1. 8 mg daily and her bg pre-vgo was 100 to 200. On vgo prior to (b)(6) 2013, patient reports her bg was in the 100 to 200 range. On (b)(6) 13 patient reported she experienced nausea, vomiting and stomach pain. Ae assessor spoke with patient on (b)(6) 13 and bg at 7:11 am = 455, at 11:21 = 362. Patient takes 2 clicks (4 units) for breakfast and lunch meal bolus, 1 click (2 units) or no clicks for dinner. Patient reported to ae assessor she was feeling very ill, ae assessor instructed patient to contact her hcp or to go to the nearest emergency facility. Patient went to local er and reports she was admitted to icy with dka diagnosis. Patient removed the vgo at the hospital on (b)(6) 2013, patient is currently on lantus 20 units and victoza 1. 8 mg. Hcp stated to valeritas customer care that the patient is a brittle diabetic.
Patient Sequence No: 1, Text Type: D, B5
[11303578]
This mdr is being filed since the patient was hospitalized during the use of the v-go 20 with symptoms of dka. Although the care does not point to device malfunction, there isn't enough information to explain the hyperglycemia. The v-go was being used during this time and patient stated that the bg levels decreased on the morning of (b)(6) 2013. The device was not available for investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226572-2013-00007 |
| MDR Report Key | 3513879 |
| Report Source | 04,CONSUMER |
| Date Received | 2013-12-11 |
| Date of Report | 2013-10-22 |
| Date of Event | 2013-10-19 |
| Date Mfgr Received | 2013-10-22 |
| Date Added to Maude | 2013-12-12 |
| 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 | 2013-12-11 |
| Model Number | V-GO 20 |
| 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, INC. |
| Manufacturer Address | 750 ROUTE 202 SOUTH SUITE 100 RIDGEWATER NJ 089072597 US 089072597 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2013-12-11 |