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 03/08/2019

Event Type  malfunction  

Manufacturer Narrative

(manufacturer narrative = t, corrected data = f) internal report: #(b)(4).Product not returned for evaluation.Most likely underlying root cause: mlc-61-improper use / mishandled by end user.Note: manufacturer contacted customer in a follow-up call to ensure that the replacement products resolved the initial concern - unable to establish contact at this time.Product notification letter sent to contact customer care.

Event Description

Consumer reported complaint for ketone strips.The customer reported complaint for negative/ no change trace results of ketone strips.The customer stated that she has been on the keto diet for some time and that the ketone test strips do not change color.The customer did not report any symptoms or medical attention.The product is stored according to specification in the bedroom.The test strip vial has not been left open and customer is following directions for proper use.The ketone test strip lot manufacturer's expiration date is 06/26/2020 and open vial date is undisclosed.

Event Description

Consumer reported complaint for ketone strips.The customer reported complaint for negative/ no change trace results of ketone strips.The customer stated that she has been on the keto diet for some time and that the ketone test strips do not change color.The customer did not report any symptoms or medical attention.The product is stored according to specification in the bedroom.The test strip vial has not been left open and customer is following directions for proper use.The ketone test strip lot manufacturer's expiration date is 06/26/2020 and open vial date is undisclosed.

Manufacturer Narrative

(manufacturer narrative = t, corrected data = t) internal report: #(b)(4).Product not returned for evaluation.Update: 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 - unable to establish contact at this time.Product notification letter sent to contact customer care.

• 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: 8604116
• MDR Text Key: 145385841
• Report Number: 1000113657-2019-00504
• 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: 07/16/2019

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 Expiration Date: 06/26/2020
• Device Model Number: KETONE STRIPS
• Device Lot Number: AV461
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Manufacturer Received: 04/24/2019
• Initial Date FDA Received: 05/13/2019
• Supplement Dates Manufacturer Received: 04/24/2019
• Supplement Dates FDA Received: 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SECOND THERAPY; SECOND THERAPY