MAUDE Adverse Event Report: GLOOKO GLOOKO DEVICE SYSTE; GLOOKO MOBILE APPLICATION FOR ANDROID

Model Number	5.x
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/15/2018
Type of Reportable Event	Malfunction
Event or Problem Description
A user reported that recent blood glucose readings from their bayer contour next one meter were not being transferred to the glooko mobile application.As a result, the user was not able to access the new blood glucose readings on the glooko application.No adverse event was reported.Glooko engineering investigated the issue and was able to reproduce it in-house, and noted that the issue was only seen with readings from bayer contour next one meters.A software update was implemented to address the syncing issue with bayer contour next one meters and the investigation was closed.

• Brand Name: GLOOKO DEVICE SYSTE
• Common Device Name: GLOOKO MOBILE APPLICATION FOR ANDROID
• Manufacturer (Section D): GLOOKO; 303 bryant street; mountain view CA 94041
• MDR Report Key: 7774755
• Report Number: 3009137498-2018-00004
• Device Sequence Number: 2217926
• Product Code: JQP
• UDI-Device Identifier: 00855093008002
• UDI-Public: (01)00855093008002(10)5.0
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 5.x
• Device Lot Number: 5.0
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2018
• Initial Report FDA Received Date: 08/10/2018
• 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