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 Code	Urinary Frequency / Polyuria (2275)
Date of Event	05/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause of malfunction: user has high glucose value (b)(4).Note: manufacturer contacted customer on (b)(4) 2017 in a follow-up call in order to ensure the customer's condition since the initial call; customer is no longer experiencing symptoms and no medical attention was required.
Event or Problem Description
Consumer reported complaint for high blood glucose test results.Sarah (wife) is calling on behalf of the customer.The customer is concerned with tests results from results obtained of 455 and 466 mg/dl.The customer's expected fasting non-fasting) blood glucose test result range is 200 mg/dl.The customer did report symptom of frequent urination.Medical attention is not reported as a result of the actual blood glucose results.The product is stored according to specification.During the call on 05/01/2017, a back to back blood test was performed by the customer fasting and produced test results of 466 and 462mg/dl using true track meter.The test strip lot manufacturer's expiration date is 03/31/2018 and open vial date is (b)(6) 2017 the meter memory was reviewed for previous test result history (date / time not set): (b)(6).Customer is concerned with high readings.Result of concern is 455mg/dl fasting.

• 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: 6590679
• Report Number: 1000113657-2017-00901
• Device Sequence Number: 719559
• Product Code: NBW
• UDI-Device Identifier: 00021292001797
• UDI-Public: (01)00021292001797
• Combination Product (Y/N): N
• Initial Reporter State: TX
• PMA/510(K) Number: K032657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 05/25/2017

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: RS4795
• 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: 05/01/2017
• Initial Report FDA Received Date: 05/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SECOND THERAPY