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	10/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient reported that their v-go fell off.The patient stated that the device fell off when they were sleeping.The device was on the back of their right arm.Additional information obtained from the patient stated that the device fell off after ten hours of wear and it was their first day of using v-go.The patient reports following directions as stated in the v-go manual; skin cleaned, wiped with alcohol pad, dried, applied to skin, fingers rubbed/pressed along the adhesive edges.She did not press the needle release button.When the device fell off the needle was exposed.She did not reapply the device after it fell off.She decided to wait until she contacted the trainer to make sure it was applied correctly.It was reported that the device was available for return to the manufacturer for evaluation.However, to date, has not be received.
Additional Manufacturer Narrative
Device evaluation: one device was received and evaluated for the device fell off event complaint.Device #(b)(6) was received and inspected.Due to the used condition of the foam pad upon receipt, the original adhesion properties could not be verified.Functional tests were performed.The adhesive pad was probed and verified that there was a moderate amount of adhesion remaining.Testing verified that the adhesion strength was sufficient.The complaint about this device 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: 18040140
• Report Number: 1226572-2023-00124
• Device Sequence Number: 17963848
• Product Code: LZG
• UDI-Device Identifier: 40385609400030
• UDI-Public: (01)40385609400030(17)260201(10)FG223047
• 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): 10/13/2023

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: 02/01/2026
• Device Model Number: V-GO 20
• Device Lot Number: FG223047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2023
• Supplement Date Received by Manufacturer: 12/12/2023
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2023
• 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: 77 YR
• Patient Sex: Female