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

Lot Number 2.6.1

Device Problem Loss of Data (2903)

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

Event Date 04/30/2018

Event Type  malfunction  

Event Description

It was reported that the user alleges the glooko application running on the (b)(4) tablet wiped a blood glucose meter data clean.No adverse event reported.

• Brand Name: GLOOKO DEVICE SYSTEM
• Type of Device: GLOOKO KIOSK APPLICATION
• Manufacturer (Section D): GLOOKO INC; 303 bryant st; mountain view CA 94041
• Manufacturer (Section G): GLOOKO INC; 303 bryant st; mountain view CA 94041
• Manufacturer Contact: tejasvi pasi ; 303 bryant st; mountain view, CA 94041 ; 6507205310
• MDR Report Key: 7555254
• MDR Text Key: 109766170
• Report Number: 3009137498-2018-00001
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130886
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/30/2018

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: Health Professional
• Device Lot Number: 2.6.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/30/2018
• Initial Date FDA Received: 05/30/2018
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other