MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,consumer report with the FDA on 2014-03-21 for V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO 20 manufactured by Valeritas, Llc.
[14877940]
Adverse event was reported to valeritas rep by certified diabetes educator who stated that diabetic (type unk) female pt was admitted to the hospital on (b)(6) 2014, with blood glucose over 700mg/dl while wearing the v-go 20 for two weeks. Adverse event assessor has made multiple attempts to obtain additional information without success.
Patient Sequence No: 1, Text Type: D, B5
[15284748]
Procedure requires filing an mdr based on the following information: pt was hospitalized with blood glucose level of over 700 mg/dl. Minimal info has been obtained in this case due to lack of response from the pt to follow-up calls and letter. No device returned for investigation. No explanation for incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226572-2014-00003 |
| MDR Report Key | 3697617 |
| Report Source | 04,CONSUMER |
| Date Received | 2014-03-21 |
| Date of Report | 2014-02-25 |
| Date of Event | 2014-02-03 |
| Date Mfgr Received | 2014-02-25 |
| Date Added to Maude | 2014-03-26 |
| 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 |
| Manufacturer Phone | 9089279920 |
| 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 | 2014-03-21 |
| 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, LLC |
| Manufacturer Address | 750 ROUTE 202 S STE 100 BRIDGEWATER NJ 088072597 US 088072597 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2014-03-21 |