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

Model Number	V-GO 20
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported expiration date is 08/05/2024 for the reported lot number.
Event or Problem Description
The patient reported that he had trouble with 3 v-go 20 devices lately where the v-go devices have come off of the back of his arm and on the abdomen no more than 5 hours into use.The patient confirmed that he uses an alcohol swab to clean the infusion site and he also shaves prior to applying the v-go.The patient mentioned that when the v-go devices come off, there is little to no adhesive that can be felt.The patient stated that he had this same problem previously off and on and estimates that it previously happened with 1 v-go out of each box since starting back in (b)(6) 2017.The patient also mentioned that he has trouble where he sweats.No device is available for return to the manufacturer for evaluation.

• 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: 15364468
• Report Number: 1226572-2022-00127
• Device Sequence Number: 6478740
• Product Code: LZG
• UDI-Device Identifier: 00385609600036
• UDI-Public: (01)00385609600036(17)240805(10)FG221166
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/15/2022

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 Model Number: V-GO 20
• Device Catalogue Number: 8560-9600-03
• Device Lot Number: VG221072C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2022
• Initial Report FDA Received Date: 09/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2021
• 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: 66 YR
• Patient Sex: Male