MAUDE Adverse Event Report: ZEALAND PHARMA U.S. INC. V-GO DISPOSABLE INSULIN DELIVERY DEVICE

Model Number	V-GO 30
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	09/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Three devices were returned and evaluated.The evaluation result is as follows: the complaint about the grey indicator not moving could not be confirmed.The 2-ring piston is at a position indicative of the device working properly.The device appears to have performed as intended.The complaint about the hyperglycemia event could not be confirmed.The device fluid path and function were tested and passed with no issue observed.The device appears to have functioned as intended.
Event or Problem Description
Patient reported that he had 2 devices which stopped delivering insulin; he noticed his bg was 300 and into the low 400s and the gray indicator was not moving.Patient experienced highs on (b)(6) 2020.The patient stated that he was prescribed v-go 40 but the pharmacy dispensed v-go 30 devices in error two weeks ago.The patient has been using v-go 30 for 2 weeks.The patient reported that he's been experiencing highs between 300-400 all day each day.On a normal day the patient's numbers are around 180.Patient stated that he didn't experience any symptoms for the hyperglycemic events and that his glucose monitor alerted him about his numbers.Patient confirmed he did not press or hit the needle release button, making the needle retract and insulin delivery cease.Patient wears the v-go device on his stomach.

• Brand Name: V-GO DISPOSABLE INSULIN DELIVERY DEVICE
• Common Device Name: V-GO
• Manufacturer (Section D): ZEALAND PHARMA U.S. INC.; 293 boston post road west; suite 330; marlborough MA 01752
• MDR Report Key: 10573093
• Report Number: 1226572-2020-00358
• Device Sequence Number: 3806410
• Product Code: LZG
• UDI-Device Identifier: 00385609600029
• UDI-Public: (01)00385609600029(17)230304(10)FG320133
• 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): 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/04/2023
• Device Model Number: V-GO 30
• Device Catalogue Number: 8560-9600-02
• Device Lot Number: VG320032B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2020
• Initial Report FDA Received Date: 09/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 53 YR