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 06/29/2016

Event Type  malfunction  

Manufacturer Narrative

(manufacturer narrative = t, corrected data = f) internal report # (b)(4).Product returned for evaluation.Root cause: black chemistry observed.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 is comfortable with results from the replacement strips.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 2 of 9.

Event Description

The customer was requesting assistance with her ketocare test strips.The customer stated that she purchased a value pack of ketocare test strips.The customer informed that one of the vials in the pack was not sealed properly and that tip of the strip is gray.The customer stated that the other vial of ketone test strips is unopened and that the tip is a beige color.The customer stated that both vials have the same lot and expiration date.No adverse event or medical intervention was reported.

Manufacturer Narrative

(manufacturer narrative = t, corrected data = t) internal report #(b)(4) product returned for evaluation.Update: root cause (rc): rc-061: storage outside specifications 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 is comfortable with results from the replacement strips.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 2 of 9.

Event Description

The customer was requesting assistance with her ketocare test strips.The customer stated that she purchased a value pack of ketocare test strips.The customer informed that one of the vials in the pack was not sealed properly and that tip of the strip is gray.The customer stated that the other vial of ketone test strips is unopened and that the tip is a beige color.The customer stated that both vials have the same lot and expiration date.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: 8506399
• MDR Text Key: 145038219
• Report Number: 1000113657-2019-00308
• 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 Expiration Date: 05/18/2017
• Device Model Number: KETONE STRIPS
• Device Lot Number: AS299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2016
• 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