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	06/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) product not returned for evaluation.No replacement product needed at this time.Complaint resolved by training during the time of the call.Most likely underlying root cause - (b)(4) passed expiration date.Test strip udi# (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 06/27/2017, 06/28/2017 and 06/29/2017.Unable to send product notification letter to customer as no address on file.Test strips are expired.Been open more than 120 days ((b)(6) 2016).
Event or Problem Description
Consumer reported complaint for e-2 error: sample not detected or using wrong test strip.The e-2 error occurred after the blood sample was absorbed.The customer's expected blood glucose test result range was undisclosed.At the time of the call on (b)(6)2017, the customer reported feeling tired and that it may be due to her thyroid.During the call on (b)(6)2017, a blood test was performed by the customer fasting and produced test result of 78 mg/dl using truetrack meter.The product is stored according to specification in the living room.The test strip lot manufacturer's expiration date is 02/28/2018 and open vial date is (b)(6) 2016.Based on strip open date provided of (b)(6)2016, customer's strips are expired - at the time of the call they are four months past the date first opened.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: 6721401
• Report Number: 1000113657-2017-01434
• Device Sequence Number: 13682859
• 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): 07/18/2017

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: 02/28/2018
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RS4771
• 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: 06/26/2017
• Initial Report FDA Received Date: 07/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1