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

Model Number	TRUETRACK
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Codes	Urinary Frequency / Polyuria (2275); Polydipsia (2604)
Date of Event	03/30/2018
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.Product is working as designed.Most likely underlying root cause: mlc-18- user has high glucose value test strip udi# (b)(4).Note: manufacturer contacted customer on (b)(4) 2018 in a follow-up call in order to ensure the customer's condition since the initial call; customer's condition had improved and he did not currently have any diabetic symptoms.The customer reported medical attention since the last call.Customer had gone to the hospital on (b)(6) 2018.Customer did not provide any information and requested a call back.Unable to contact the customer to obtain details about the hospital visit.Unabled to send product notification letter as no address on file for customer.
Event or Problem Description
Consumer initially called regarding code ----.During troubleshooting, a back to back blood test was performed by the customer non-fasting and produced test results of hi and hi using truetrack meter.The customer stated that his blood glucose runs over 600 mg/dl all the time (fasting and non-fasting).At the time of the call the customer reported symptoms of increased urination and dry mouth.Customer stated he was going to seek medical intervention.Customer just received the test strips on (b)(6) 2018.The test strip lot manufacturer's expiration date is 04/30/2020 and open vial date is (b)(6) 2018.The truetrack meter is new and there are no results in the meter memory.The meter memory was not reviewed for previous test result history.No results on the memory because it's a new meter.

• 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: 7454710
• Report Number: 1000113657-2018-00471
• Device Sequence Number: 1084192
• Product Code: NBW
• UDI-Device Identifier: 00021292001018
• UDI-Public: (01)00021292001018
• 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): 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/30/2020
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RU5191
• 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: 03/30/2018
• Initial Report FDA Received Date: 04/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1