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 06/19/2018

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-20-user's test strip had poor storage (bathroom) note: manufacturer contacted customer (several attempts) 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.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 9 of 9.

Event Description

Customer calling regarding ketone test strips being open in sealed box when customer initially purchased container and discoloration.Customer is storing strips in bathroom.Informed customer of proper storage areas dry room temperature area.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
• Manufacturer Contact: karen devincent ; 2400 nw 55th court; fort lauderdale, FL 33309 ; 954677-920
• MDR Report Key: 8507089
• MDR Text Key: 145039000
• Report Number: 1000113657-2019-00315
• 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: 04/11/2019

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: AU385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Manufacturer Received: 03/18/2019
• Initial Date FDA Received: 04/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1