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	Hypoglycemia (1912); Discomfort (2330)
Date of Event	06/01/2024
Type of Reportable Event	Serious Injury
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.The patient reported that he had several episodes of low glucose.He was sweating and didn't feel well.His glucose went to 70 but continued to drop to 50.He removed the device to stop the insulin.He states he had 2 slices of spam which raised his glucose level to 100.He also said he eats lays potato chips to raise his glucose.It is possible the device contributed to the ae of hypoglycemia.The patient did not know details regarding dates and times.
Event or Problem Description
The patient reported that the v-go device delivered too much insulin and the patient's blood sugar dropped.The patient reported that they couldn't figure out why their blood sugars were so variable and talked to the pharmacist who said it might be the v-go malfunctioning.The patient reported his blood sugar was 70 and then went down to 50 and he had to take his v-go off to keep it from dropping more - he did not click the bolus button prior to this incidence.The patient stated there are no devices 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: 19690339
• Report Number: 1226572-2024-00035
• Device Sequence Number: 7155924
• 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 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 Sex: Male