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

Model Number	TRUETRACK
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	Fatigue (1849)
Date of Event	12/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) (b)(4).Product not returned for evaluation.No replacement product needed at this time.Complaint resolved by training during the time of the call.Product is working as designed.Most likely underlying root cause: mlc-68-user did not insert code key test strip (b)(4).Note: manufacturer contacted customer (several attempts) in a follow-up call in order to ensure the customer's condition since the initial call - unable to contact the customer via telephone at call backs on 12/19/2017, 12/20/2017 and 12/21/2017.Unable to send product notification as no address on file for customer.
Event or Problem Description
Consumer reported complaint for code (----) eci meter.Customer was getting code (----) when the test strips were inserted into the meter.The customer's expected blood glucose test result range was undisclosed.At the time of the call the customer reported feeling fatigued and felt that it was related to his blood glucose being elevated.Customer has not been diagnosed with diabetes and just bought the truetrack meter due to feeling fatigued.Customer stated he was going to go to the emergency room.During the call on (b)(6) 2017, a blood test was performed by the customer non-fasting using a new vial of test strips and produced test result of 541 mg/dl using truetrack meter.The product storage was undisclosed.The test strip lot manufacturer's expiration date is 04/30/2019 and open vial date was undisclosed.The meter memory was not reviewed for previous test result history.

• Brand Name: TRUETRACK
• Common Device Name: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 7185579
• Report Number: 1000113657-2018-00045
• Device Sequence Number: 16416604
• Product Code: NBW
• UDI-Device Identifier: 00050428264706
• UDI-Public: (01)00050428264706
• Combination Product (Y/N): N
• PMA/510(K) Number: K032657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/12/2018

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/30/2019
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RT5025
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2017
• Initial Report FDA Received Date: 01/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1