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

Model Number 5.x

Device Problems Computer Software Problem (1112); Failure to Transmit Record (1521)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/15/2018

Event Type  malfunction  

Event 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
• Type of Device: GLOOKO MOBILE APPLICATION FOR ANDROID
• Manufacturer (Section D): GLOOKO; 303 bryant street; mountain view CA 94041
• Manufacturer Contact: tejasvi pasi ; 303 bryant st; mountain view, CA 94041
• MDR Report Key: 7774755
• MDR Text Key: 117165488
• Report Number: 3009137498-2018-00004
• Device Sequence Number: 1
• Product Code: JQP
• UDI-Device Identifier: 00855093008002
• UDI-Public: (01)00855093008002(10)5.0
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: 5.x
• Device Lot Number: 5.0
• Initial Date Manufacturer Received: 07/15/2018
• Initial Date FDA Received: 08/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other