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 Codes	Blurred Vision (2137); Urinary Frequency / Polyuria (2275)
Date of Event	06/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report # (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 6/30/2017 in a follow-up call in order to ensure the customer's condition since the initial call; customer condition improved.No symptoms or medical attention reported since the original call.Customer satisfied with the product.
Event or Problem Description
Consumer reported complaint for e-5 error code accompanied by symptoms.The expected fasting blood glucose test result range is undisclosed.The customer did report symptoms of blurry vision and frequent urination medical attention is not reported as a result of the actual blood glucose results and reported symptoms.The product is stored by customer according to specification.During the call on (b)(6) 2017, a blood test was performed fasting by the customer and produced test results of 483mg/dl using true track meter.The test strip lot manufacturer's expiration date is 05/28/2019 and open vial date is within the month of (b)(6) 2017.The meter memory was not reviewed for previous test result history.Customer complaining for e-5 message when blood is absorbed.Customer reports symptoms of blurry vision and frequent urination.After troubleshooting customer was able to obtain a blood glucose result.

• 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: 6711858
• Report Number: 1000113657-2017-01417
• Device Sequence Number: 1601805
• Product Code: NBW
• UDI-Device Identifier: 00011822577540
• UDI-Public: (01)00011822577540
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 07/13/2017

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 Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RT5046
• 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: 06/19/2017
• Initial Report FDA Received Date: 07/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1