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

Model Number	V-GO 30
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Codes	Hyperglycemia (1905); Discomfort (2330); Unspecified Eye / Vision Problem (4471)
Date of Event	06/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported that the v-go did not deliver enough insulin and their blood sugar stayed high.It was reported that the patient couldn't figure out why his blood sugars were so variable and talked to the pharmacist who said it might be the v-go malfunctioning.His blood sugars got up to 435 and would not go down even with the v-go on, and with bolus clicks.He didn't have any changes in diet to explain this spike in blood sugar.It was reported that there are no devices available for return to the manufacturer for evaluation.
Additional Manufacturer Narrative
Adverse event (ae) assessment: ae assessor spoke to the long-term v-go 30 user.He started out using a v-go 40 but was reduced to the v-go 30.He started out as a type 2 diabetic but was told he no longer makes insulin.He is now a type 1 diabetic.He uses humalog insulin.He rotates the device site between his arms and his abdomen.He wears a libre 2 continuous glucose monitor (cgm).He gives 4-5 clicks per meal.He has an active job.He has recently had issues with multiple devices from the same box.He did not save any of the devices in question.He states he has had a high reading of 425 last week.He states he had visual changes and felt sick.For dinner that day he had eaten a salad and cheesy bread.He had given his clicks before he ate.He stated he gave extra clicks and ate two boiled eggs which leveled his sugar off at 175.The patient states some of the devices emptied in 6-7 hours after applying.He felt that the device worked in the opposite manner of what it should.A glucose level over 400 is a serious high especially for a type one diabetic.He could benefit from diabetic education.It is possible the device contributed to the ae of hyperglycemia.The patient did not know details regarding dates and times.

• 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: 19689809
• Report Number: 1226572-2024-00034
• Device Sequence Number: 8009515
• Product Code: LZG
• UDI-Device Identifier: 00385609400025
• UDI-Public: (01)00385609400025(17)260110(10)FG323143
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 06/17/2024

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: 01/10/2026
• Device Model Number: V-GO 30
• Device Lot Number: FG323143
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2023
• 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 Sex: Male