MAUDE Adverse Event Report: MANNKIND CORPORATION - V-GO V-GO DISPOSABLE INSULIN DELIVERY DEVICE

Model Number	V-GO 30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Skin Infection (4544); Skin Inflammation/ Irritation (4545)
Date of Event	08/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Adverse event (ae) assessment: ae assessor contacted the v-go client.The client has type 2 diabetes, lispro insulin and used the v-g0 30 device for 1 year.Client reports following the directions per the v-go manual for skin preparation and placement.Skin was clean, dried, wiped with alcohol pad, placed on his abdomen, rotating sides and locations.He experienced difficulty removing the adhesive tape, tacky residue built up on his skin.Skin became irritated, rash, oozing, bleeding and developed a small hole under the v-go device.He stopped wearing the device.He self-treated the area with neosporin.He has followed up with his healthcare professional (hcp).No additional medical treatment was needed.August 1 month later the hole has closed, and he has a small scar.His hcp advised he contact the company regarding his skin.He has stopped using the v-go device and does not plan to restart.The v-go adhesive is medical grade hypoallergenic, however some people may have a reaction.It is possible the v-go device contributed to his skin reaction.Device evaluation: the device was returned to the manufacturer on 09/14/2023.The investigation results are pending and will be submitted via follow-up report.
Event or Problem Description
The patient reported that he got a skin infection from the adhesive on the v-go 30.It was reported that samples are available for return to the manufacturer for evaluation.
Additional Manufacturer Narrative
Device evaluation: twenty-seven unused and unopened v-go were returned.Skin irritation and the reported infection cannot be directly assessed by mannkind corp.The original device was not returned and thus no direct assessment of the device in question could be conducted.One of the unused devices was removed from the packaging and probed with a glove hand.The adhesive tack appeared to be typical of other unused devices.There does not appear to be a distinct difference in adhesion performance from normal.A review of the lots associated with this foam pad lot resulted in no trend or additional complaints with a similar narrative.There were no anomalies observed within the documentation regarding the build or component lots.The reported complaint could not be confirmed.

• Brand Name: V-GO DISPOSABLE INSULIN DELIVERY DEVICE
• Common Device Name: V-GO
• Manufacturer (Section D): MANNKIND CORPORATION - V-GO; 293 boston post road w; #330; marlborough MA 01752
• Manufacturer (Section G): MANNKIND CORPORATION - V-GO; 293 boston post road w; #330; marlborough MA 01752
• Manufacturer Contact: jeffrey zajac ; 293 boston post road w; #330; marlborough, MA 01752
• MDR Report Key: 17747700
• Report Number: 1226572-2023-00106
• Device Sequence Number: 5461282
• Product Code: LZG
• UDI-Device Identifier: 00385609400025
• UDI-Public: (01)00385609400025(17)250805(10)FG322105
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K103825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/09/2025
• Device Model Number: V-GO 30
• Device Lot Number: VG322056C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2023
• Supplement Date Received by Manufacturer: 09/26/2023
• Initial Report FDA Received Date: 09/14/2023
• Supplement Report FDA Received Date: 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR
• Patient Sex: Male