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

Model Number	V-GO 30
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	12/22/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The patient reported that the needle button released before the 24 hour period today.The patient indicated that this happened after having the v-go for approximately 13 hours.The patient was advised to remove the v-go after the call and place a new v-go on her body.The patient indicated that she uses the v-go on her abdomen.The patient indicated that she is using the v-go since yesterday.The patient that she experienced hyperglycemia today.The patient reported the following readings today (b)(6) 2020: -around 9:30 a.M.Of 215-before dinner of 267-during the call at 7:43 p.M.Of 334.The patient indicated that her normal readings are between 140-200.
Additional Manufacturer Narrative
The device was returned and evaluated.The evaluation results are as follows: the device was received and evaluated for the complaint regarding the needle button release event.The device was received with the needle button depressed with a bent straight needle.The needle release button was in the depressed (step 2 of 2) position which is in the activated lockout position.The needle mechanism was tested and was verified to have operated as intended.The complaint could not be confirmed for this device.

• 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: 11169632
• Report Number: 1226572-2020-00479
• Device Sequence Number: 2765866
• Product Code: LZG
• UDI-Device Identifier: 00385609600029
• UDI-Public: (01)00385609600029(17)220821(10)FG320106
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 12/22/2020

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/21/2022
• Device Model Number: V-GO 30
• Device Catalogue Number: 8560-9600-02
• Device Lot Number: FG320106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Initial Date Received by Manufacturer: 12/22/2020
• Supplement Date Received by Manufacturer: 12/22/2020
• Initial Report FDA Received Date: 01/14/2021
• Supplement Report FDA Received Date: 03/02/2021
• 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: Other
• Patient Age: 57 YR