MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-12-11 for V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO 20 manufactured by Valeritas, Inc.
[3993628]
During an outbound call from adverse event assessor on (b)(6) 2013 (regarding an unrelated issue), patient (b)(6) caregiver reported that vgo 20 user with shwachman-diamond syndrome was hospitalized for a skin infection (pseudomonas) at a vgo needle insertion site on the abdomen on (b)(6) 2013. Caregiver reported that on (b)(6) 2013 at 09:00 am, she noticed what appeared to be a "small pimple" on abdomen of patient, applied (b)(6) on "the pimple". At 01:00 pm, caregiver noticed the "pimple" changed to completely black in color and patient had a temperature of 102. 7 with chills. Caregiver contacted patient hematologist by phone and was advised to take patient to local er. Caregiver reported that as a result of shwachman-diamond syndrome, patient has blood dyscrasias which can interfere with patient's ability to heal from infection. Caregiver reports that infectious disease doctor stated the vgo was the source of infection. Caregiver stated the infection was an opportunistic infection. Patient was discontinued from vgo after hospital admission and is still in the hospital at this time receiving treatment for the skin infection. Caregiver stated hcp told them the patient is not a candidate for the vgo due to her medical history.
Patient Sequence No: 1, Text Type: D, B5
[11324246]
V-go's are terminally sterilized to a sal (sterility assurance level) of (b)(4) which means that there is a statistical probability that only (b)(4) may not be sterile. Therefore, the likelihood that the infection was caused by the device is extremely low, but not impossible. No lot number was provided to review sterilization records. The most likely cause of the infection would be due to the patient's pre-existing condition which causes a immune deficiency. As a result, patients with shwachman-diamond syndrome are more vulnerable to infections such as pneumonia, recurrent ear infection (otitis media), and skin infections.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226572-2013-00006 |
| MDR Report Key | 3513880 |
| Report Source | 04 |
| Date Received | 2013-12-11 |
| Date Added to Maude | 2013-12-16 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SCOTT HUIE |
| Manufacturer Street | 800 BOSTON TURNPIKE |
| Manufacturer City | SHREWSBURY MA 01545 |
| Manufacturer Country | US |
| Manufacturer Postal | 01545 |
| 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 | UNKNOWN |
| 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 SUITE 100 BRIDGEWATER NJ 08807259 US 08807 2597 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2013-12-11 |