MAUDE Adverse Event Report: GLOOKO INC GLOOKO MOBILE APPLICATION FOR IOS

Lot Number 5.5

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 06/13/2019

Event Type  malfunction  

Event Description

A glooko user reported that the glooko mobile application for ios was incorrectly displaying retrospective "high" and "low" cgm values.No adverse event was reported.The glooko engineering team investigated the issue and a software fix will be implemented.

• Brand Name: GLOOKO MOBILE APPLICATION FOR IOS
• Type of Device: GLOOKO MOBILE APPLICATION FOR IOS
• Manufacturer (Section D): GLOOKO INC; 303 bryant st; mountain view CA 94041
• Manufacturer Contact: tejasvi pasi ; 303 bryant st; mountain view, CA 94041
• MDR Report Key: 8787041
• MDR Text Key: 151034431
• Report Number: 3009137498-2009-00007
• Device Sequence Number: 1
• Product Code: PHV
• 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: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 5.5
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/13/2019
• 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