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

Model Number	TRUETRACK
Date of Event	08/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not returned for evaluation.No replacement product needed at this time.Product is working as designed.Customer disconnected the call.Most likely underlying root cause: mlc-62-user had poor technique.Test strip udi# (b)(4).Manufacturer contacted customer (several attempts) in a follow-up call in order to ensure the customer's condition since the initial call - unable to establish contact with the customer at this time.Unable to send product notification letter as no address on file.
Event or Problem Description
Consumer reported complaint for e-3 error code; used test strip, test strip outside of vial too long, sample on top of test strip.The e-3 error occurred when the blood sample was absorbed.Prior to call being transferred, a blood test had been performed by customer and produced test result of 441 mg/dl using truetrack meter; customer stated she was not concerned with the result.The customer's expected blood glucose test result range was not disclosed.At the time of the call, the customer stated that she was feeling funny and shaky.Medical attention was not needed at the time of the call.The product is stored according to specification in the bedroom.The test strip lot manufacturer's expiration date is 11/30/2020 and open vial date was undisclosed.The meter memory was not reviewed for previous test result history.Customer had disconnected the call during the troubleshooting process.

• 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: 7878363
• Report Number: 1000113657-2018-00953
• Device Sequence Number: 10811043
• Product Code: NBW
• UDI-Device Identifier: 00011822577540
• UDI-Public: (01)00011822577540
• 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): 09/14/2018

1 Device 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: 11/30/2020
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RV5270
• 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: 08/22/2018
• Initial Report FDA Received Date: 09/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No