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 Device Problem Information (3190)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	07/09/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The patient mentioned that she is experiencing hyperglycemia and the bolus delivery button locking out before 18 clicks.The patient mentioned that she keeps 5 pre-filled v-go's in her refrigerator but is unsure of the insulin brand name to confirm storage conditions.The patient provided the following readings on 7/9 - 7/11 but stated that she was not on v-go while checking her readings through finger pricks, also stating that 7/09 was written down as the start date -- 7/09 - 415 at 5:09am, 350 at 8:02am, 450 at 3:15pm, 500 at 6:45pm; 7/10 - 446 at 1:00am, 403 at 6:45am, 393 at 3:10pm, 381 at 9:25pm; 7/11 - 434 at 1:10am.The patient provided the following readings while on v-go -- day 3 - 429 before breakfast; day 4 - "high" before breakfast, 318 before lunch, 436 before dinner; day 5 - "high" before breakfast, 407 before lunch, 499 before dinner; day 6 - 454 before breakfast, 448 before lunch, "high" before dinner; day 7 - 377 before breakfast, "high" before lunch, 407 before dinner, day 8 - 326 before breakfast.289 before lunch, 347 before dinner.The patient mentioned a nurse advised her to go to the hospital on 7/14 and she went to the emergency room where they gave her an iv and sent her home later in the day.The patient mentioned that the bolus delivery buttons are locking out.The patient stated that she has been taking 4 clicks before meals, 1 click before snacks and does not think she exceeded 18 clicks.

• 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
• MDR Report Key: 10394416
• Report Number: 1226572-2020-00250
• Device Sequence Number: 16826237
• Product Code: LZG
• UDI-Device Identifier: 00385609600029
• UDI-Public: (01)00385609600029(17)200419(10)FG317081
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/16/2020

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/19/2020
• Device Model Number: V-GO 30
• Device Catalogue Number: 8560-9600-02
• Device Lot Number: FG317081
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2020
• Initial Report FDA Received Date: 08/11/2020
• 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: Hospitalization
• Patient Age: 83 YR