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

Model Number KETONE STRIPS

Device Problem Display Difficult to Read (1181)

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

Event Date 03/27/2019

Event Type  malfunction  

Manufacturer Narrative

(manufacturer narrative = t, corrected data = f) internal report: # (b)(4).Product was returned and evaluated - reported defect not reproduced.Most likely underlying root cause: mlc-1 user had an inaccurate reference.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 he is comfortable with the replacement product.

Event Description

Consumer reported complaint for negative/no change trace results with ketone strips.Customer stated that the color is not changing like it should, states that certain part of the pad will change color, but some does not.Some of the port of the strips will change and then some parts of the strips will stay beige.Customer test 2-3 strips as the same time and have been using these strips for some time now.The customer did not report symptoms or medical attention.The product is not stored according to specification in the bathroom.The ketone test strip lot manufacturer's expiration date is undisclosed and open vial date is undisclosed.

Manufacturer Narrative

(manufacturer narrative = t, corrected data = t) internal report: #(b)(4).Product was returned and evaluated - reported defect not reproduced.Update: most likely underlying root cause: mlc-28: there was not enough information to determine the mlurc.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 he is comfortable with the replacement product.

Event Description

Consumer reported complaint for negative/no change trace results with ketone strips.Customer stated that the color is not changing like it should, states that certain part of the pad will change color, but some does not.Some of the port of the strips will change and then some parts of the strips will stay beige.Customer test 2-3 strips as the same time and have been using these strips for some time now.The customer did not report symptoms or medical attention.The product is not stored according to specification in the bathroom.The ketone test strip lot manufacturer's expiration date is undisclosed and open vial date is undisclosed.

• 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: 8541488
• MDR Text Key: 145113682
• Report Number: 1000113657-2019-00378
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 07/17/2019

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: AV467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2019
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Manufacturer Received: 03/27/2019
• Initial Date FDA Received: 04/23/2019
• Supplement Dates Manufacturer Received: 03/27/2019
• Supplement Dates FDA Received: 07/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SECOND THERAPY; SECOND THERAPY