MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,consumer report with the FDA on 2014-03-11 for V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO 40 manufactured by Valeritas, Llc.
[4290831]
Pt with type 2 diabetes reported high bg values while wearing v-go insulin delivery device to valeritas call center. Pt reports that while on v-go 40 he was hospitalized on (b)(6) 2014 with dka. As noted by pt's fiancee, on the afternoon of (b)(6) 2014 pt was acting "delirious, confused, falling into things". She then measured his bg at "hi". The fiancee contacted his hcp who recommended 6 clicks (12u) bolus. When bg did not decrease hsp recommended that pt be taken to emergency department (ed). Pt reports the following treatment during hospitalization: at ed, pt bg measured 529 mg/dl; pt was admitted overnight and bg was managed via insulin injection; per patient he was released the next day with bg of approximately 400mg/dl. Pt and fiancee are confident that they applied and used the b-go correctly. Pt confirms that "insulin was going in". Pt denies any current or recent illness, infection, change in diet or exercise or other factors which could cause or contribute to hyperglycemia. Pt confirms that he did deliver his bolus dose of 6 clicks per meal. There is no suggestion of device malfunction.
Patient Sequence No: 1, Text Type: D, B5
[11572322]
Patient stated that he had been using the product for one day only. Mdr (is being submitted per our procedure since: patient required medical intervention and was hospitalized with diabetic ketoacidosis (dka). No device was returned for investigation so cannot determine whether the hyperglycemia was due to the device not working correctly or due to user error.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226572-2014-00002 |
| MDR Report Key | 3678623 |
| Report Source | 04,CONSUMER |
| Date Received | 2014-03-11 |
| Date of Report | 2014-02-24 |
| Date of Event | 2014-02-21 |
| Date Mfgr Received | 2014-02-24 |
| Date Added to Maude | 2014-03-18 |
| 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 | 2014-03-11 |
| Model Number | V-GO 40 |
| Lot Number | FG213117 |
| Device Expiration Date | 2014-08-01 |
| 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, LLC |
| Manufacturer Address | 800 BOSTON TURNPIKE SUITE 100 BRIDGEWATER NJ 088072597 US 088072597 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2014-03-11 |