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.
[4267882]
Type 2 diabetic female pt per physician has been on v-go 20 1-2 weeks. The pt reports she had a blood glucose of 11 mg/dl on (b)(6) 2014 about 9:30am. The pt reports she had just fixed her breakfast, was walking to the parlor and passed out. Her husband found her on the floor and called the rescue squad. The rescue squad removed the v-go. She was treated and hospitalized. In the hospital she indicated she had high blood glucose of 248, 300, and 209 mg/dl. The pt reported she did not use the clicks (mealtime bolus) while using the v-go. She indicated she changed the v-go every day at 8am. When asked if she saw insulin left in the v-go when she removed it she reported there was no insulin left. She reported she had blood glucose of 30, 35, 40, 57, and 63 mg/dl while using the vgo and her symptom was shakiness. The pt indicated she had reported these blood glucose readings to her health care provider. The pt also reported her blood glucose was also 1999 and 300mg/dl while using the v-go. The pt indicated she was checking her blood glucose 4x day and the blood glucose could be any level any time; there was no pattern. The pt indicated there was no differences in lifestyle except she was gaining weight. She reported treating the low blood glucose with orange juice. She reported she ate normally the day before the blood glucose of 11 mg/dl. She reported she often does not take bedtime snack but if she does it is peanut butter and crackers. The pt reported she does not know her aic. The pt reports pre-vgo she was taking 20 units of lantas twice a day and novolog of 10 units twice a day. She indicated she took the same oral medications pre-vgo and when using the vgo of 15mg of actos in the am, glipizide 10mg twice a day and metformin 500 mg twice a day. Pre-vgo the pt reports her blood glucose range was 200-500mg/dl. She reported the lowest blood glucose she ever had pre-vgo was 82mg/dl without symptoms.
Patient Sequence No: 1, Text Type: D, B5
[11619438]
Procedure requires filing an mdr based on the following info: pt had blood glucose reading level of 11mg/dl. Pt passed out and was unable to recognize and treat the event without third party intervention. Pt was hospitalized. Device was not available for investigation so no contributory cause could be identified for the low blood glucose reading.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226572-2014-00004 |
| MDR Report Key | 3697644 |
| Report Source | 04,CONSUMER |
| Date Received | 2014-03-21 |
| Date of Report | 2014-02-28 |
| Date of Event | 2014-02-28 |
| Date Mfgr Received | 2014-02-28 |
| 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 | 908927920 |
| 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 |