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

Model Number KETONE STRIPS

Device Problem Insufficient Information (3190)

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

Event Date 01/30/2019

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-28 there was not enough information to determine the mlurc.Note: manufacturer is unable to reach to customer since no customer address on file nor email/phone information.

Event Description

Consumer reported complaint for inaccurate results.The customer is concerned with tests results obtained are not being in ketosis while another brand results are in ketosis.The customer did not report symptoms neither medical attention.The product storage location is undisclosed.The ketone 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 not returned for evaluation.Update: most likely underlying root cause: mlc-1:user had an inaccurate reference.Note: manufacturer is unable to reach to customer since no customer address on file nor email/phone information.

Event Description

Consumer reported complaint for inaccurate results.The customer is concerned with tests results obtained are not being in ketosis while another brand results are in ketosis.The customer did not report symptoms neither medical attention.The product storage location is undisclosed.The ketone 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: 8511860
• MDR Text Key: 145112883
• Report Number: 1000113657-2019-00321
• 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: Other
• 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 Model Number: KETONE STRIPS
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Manufacturer Received: 03/19/2019
• Initial Date FDA Received: 04/12/2019
• Supplement Dates Manufacturer Received: 03/19/2019
• 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