MAUDE Adverse Event Report: TRIVIDIA HEALTH, INC. N/A; BLOOD GLUCOSE SYSTEM

Model Number KETONE STRIPS

Device Problem Ambient Temperature Problem (2878)

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

Event Date 02/06/2018

Event Type  malfunction  

Manufacturer Narrative

(manufacturer narrative = t, corrected data = f) internal report: # (b)(4).Returned ketone strips evaluated with no defects found.Most likely underlying root cause: mlc-50 manufacturing process caused malfunction of user's test strip.Note: manufacturer contacted customer in a follow-up call to ensure that the replacement products resolved the initial concern - able to establish contact with customer who indicated that the replacement strips are working as they should.Note: manufacturer reviewed and updated the risk analysis report for the ketone strips on march 2019.Customer complaints for open vial were reviewed for possible mdr based on internal update of the risk report and the severity of harm, the complaint is reportable, however no adverse event or medical intervention was reported at the time of the call.Complaint 8 of 9.

Event Description

Customer says that she purchased a box of ketone strips 100 count.Customer says that one of the containers of 50 was opened/not snapped shut.Customer realized this when she opened the box today.No adverse event or medical intervention was reported.

Manufacturer Narrative

(manufacturer narrative = t, corrected data = t) internal report: #(b)(4) returned ketone strips evaluated with no defects found.Update most likely underlying root cause: mlc-28 there was not enough information to determine the mlurc.Note 1: manufacturer contacted customer in a follow-up call to ensure that the replacement products resolved the initial concern - able to establish contact with customer who indicated that the replacement strips are working as they should.Note 2: manufacturer reviewed and updated the risk analysis report for the ketone strips on march 2019.Customer complaints for open vial were reviewed for possible mdr based on internal update of the risk report and the severity of harm, the complaint is reportable, however no adverse event or medical intervention was reported at the time of the call.Complaint 8 of 9.

Event Description

Customer says that she purchased a box of ketone strips (b)(4) count.Customer says that one of the containers of (b)(4) was opened/not snaped shut.Customer realized this when she opened the box today.No adverse event or medical intervention was reported.

• Brand Name: N/A
• Type of Device: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 8507061
• MDR Text Key: 145095738
• Report Number: 1000113657-2019-00314
• Device Sequence Number: 1
• Product Code: JIN
• Combination Product (y/n): N
• PMA/PMN Number: K000000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 07/12/2019

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: Lay User/Patient
• Device Model Number: KETONE STRIPS
• Device Lot Number: AU383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Manufacturer Received: 03/18/2019
• Initial Date FDA Received: 04/11/2019
• Supplement Dates Manufacturer Received: 03/18/2019
• Supplement Dates FDA Received: 07/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SECOND THERAPY; SECOND THERAPY