MAUDE Adverse Event Report: GLOOKO INC GLOOKO DEVICE SYSTEM; GLOOKO WEB APPLICATION

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 03/14/2019

Event Type  malfunction  

Event Description

A hcp user reported that after uploading a diabetes device via the glooko transmitter, the device offset label on the glooko web application is not displaying the correct offset information.No adverse event was reported.The glooko engineering team was able to reproduce the issue and a software fix will be implemented.

• Brand Name: GLOOKO DEVICE SYSTEM
• Type of Device: GLOOKO WEB APPLICATION
• Manufacturer (Section D): GLOOKO INC; 303 bryant street; mountain view CA 94041
• Manufacturer Contact: tejasvi pasi ; 303 bryant st; mountain view, CA 94041 ; 6507205310
• MDR Report Key: 8504758
• MDR Text Key: 145656806
• Report Number: 3009137498-2019-00006
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/11/2019

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: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2019
• Initial Date FDA Received: 04/11/2019
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other