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

Model Number	V-GO 40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	07/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported high blood sugars on (b)(6) 2024 to 700 (mg/dl).The patient reported her sugars were 100 in the morning, then she got imaging and contrast dye, the evening sugars were 400.She said the "pump wasn't doing anything" so she took it off and took her regular insulin regimen.It was reported that the device samples are available for return to the manufacturer for evaluation.
Additional Manufacturer Narrative
Adverse event (ae) assessment: the ae assessor has not been able to reach the patient for further investigation of the complaint.Without speaking with the patient, the ae assessor is unable to fully understand the contributing factors.The patient reported her blood sugar was 100 mg/dl at the start of the day, she received imaging with contrast dye and the blood glucose increased to as high as 700 mg/dl but when it was 400 mg/dl in the evening she removed the v-go and took her regular insulin regimen.The v-go manual states the patient should remove v-go before having an x-ray, mri, or ct scan (or any similar test or procedure).Replace with a new v-go after the test or procedure is completed.The patient indicated she removed her v-go after her high blood glucose of 400mg/dl in the evening, but the initial call indicated the bg rose to 700mg/dl when it was highest.The v-go was to be removed before the imaging procedure according to the instructions for patient use.The imaging procedure may affect the v-go operation.A new v-go would need to be placed after the imaging procedure.High blood glucose could also possibly be explained by other factors affecting the bg level including stress, hormonal changes, medication, physical activity, diet, level of sleep, dehydration and pain.However, the most likely explanation is that the v-go was not removed before the imaging procedure.This case is a serious case due to the bg level of 700 mg/dl and the patient has type 1 diabetes.Device evaluation: three devices were received and evaluated for the complaint.All devices were inspected, and the functions were tested and verified to have operated as intended.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: 20129331
• Report Number: 1226572-2024-00051
• Device Sequence Number: 17991696
• Product Code: LZG
• UDI-Device Identifier: 00385609400018
• UDI-Public: (01)00385609400018(17)260417(10)FG423091
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/12/2024

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: 04/17/2026
• Device Model Number: V-GO 40
• Device Lot Number: FG423091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female