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

Model Number	V-GO 30
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Codes	Rash (2033); Needle Stick/Puncture (2462); Skin Inflammation/ Irritation (4545)
Date of Event	06/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Adverse event (ae) assessment: ae assessor attempted multiple times to contact the vgo user.There was no return contact.The patient had called into vcc with complaints of devices falling off.He had one complaint of a needle coming loose and poking him.He also complained of developing a rash where the device was, for which he went to see a dermatologist.There is limited detailed information provided.The patient developed a skin reaction to the adhesive.He sought treatment from a dermatologist.This is not a severe adverse reaction; the device uses medical grade hypoallergenic adhesive however some people may develop a reaction.It is not known how his glucose was affected when his device fell off.It is not known how he prepped the skin or where he wears it.This is not a serious adverse event.There is not enough information, but it is possible the device contributed.Device evaluation: nine devices were received and evaluated for the device fell off event.All devices were evaluated, and no issue was observed.Due to the used condition of the foam pad, the original adhesion properties could not be verified.The complaint about these devices could not be confirmed.
Event or Problem Description
The patient reported that their last box of v-go's are completely falling off and he had to stop using them.The patient reported that one of the devices had the needle stick/scratch him before falling off.The patient reported nine devices fell off, however the exact event dates for each were not reported.The patient reported getting an awful rash on arm and stomach area which crusted over.The patient reported he will go see a dermatologist.The devices were reported to be available for return to the manufacturer for evaluation.
Additional Manufacturer Narrative
Additional device evaluation: an additional seven devices were received and evaluated for the device fell off complaint.All device functions were tested, and no issue was observed.Due to the used condition of the foam pad, the original adhesion properties could not be verified.The complaint about these devices 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: 17202717
• Report Number: 1226572-2023-00053
• Device Sequence Number: 6742004
• Product Code: LZG
• UDI-Device Identifier: 00385609400025
• UDI-Public: (01)00385609400025(17)250727(10)FG322102
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/27/2025
• Device Model Number: V-GO 30
• Device Catalogue Number: 8560-9400-02
• Device Lot Number: FG322102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2023
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2022
• 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
• Patient Age: 64 YR
• Patient Sex: Male