MAUDE Adverse Event Report: TRIVIDIA HEALTH, INC. KETONE STRIPS; BLOOD GLUCOSE SYSTEM

Model Number KETONE STRIPS

Device Problem Unable to Obtain Readings (1516)

Patient Problems Headache (1880); Diabetic Ketoacidosis (2364)

Event Date 02/01/2018

Event Type  malfunction  

Manufacturer Narrative

(manufacturer narrative = t, corrected data = f) internal report # (b)(4).Ketone strips were returned for evaluation.No defect was detected.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 - at a call back on (b)(6) 2018, the customer's condition had improved and she did not currently have any diabetic symptoms.No medical intervention since the last call was reported.Note: manufacturer reviewed and updated the risk analysis report for the ketone strips on march 2019.Customer complaints for open vial and others 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 14.

Event Description

Customer stated that the ketone strips she purchased yesterday were not changing color.Customer had used ten ketone test strips.Customer was storing test strips in the bathroom and was advised of proper strip storage.Customer stated she has diabetic ketoacidosis and has lost weight and wanted to check for ketones.At the time of the call the customer stated she had a headache.Customer denied the need for medical attention at the time of the call.No adverse event or medical intervention was reported.

• Brand Name: KETONE STRIPS
• Type of Device: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• Manufacturer Contact: karen devincent ; 2400 nw 55th court; fort lauderdale, FL 33309 ; 954677-920
• MDR Report Key: 8719805
• MDR Text Key: 149524856
• Report Number: 1000113657-2019-00651
• 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
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 06/20/2019

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: 04/24/2019
• Device Model Number: KETONE STRIPS
• Device Lot Number: AU376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Manufacturer Received: 05/28/2019
• Initial Date FDA Received: 06/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1