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

Model Number	TRUETRACK
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned meter evaluated with no defect found.Test strips not returned for evaluation.Most likely underlying root cause: mlc-134-user has low glucose value.(b)(4).
Event or Problem Description
Customer initially called for training on how to use the truetrack meter.The customer has had the meter for a while and just bought a new vial of test strips and started to use it again.During the call on (b)(6) 2017, a back to back blood test was performed by the customer non-fasting and produced test results of lo and 124 mg/dl using truetrack meter.The customer is concerned with the result obtained of lo.The customer did not know his expected blood glucose test result range.The customer feels well and did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product is stored according to specification.The test strip lot manufacturer's expiration date is 05/31/2019 and open vial date is 12/04/2017.The meter memory was reviewed for previous test result history: result 1 :124 mg/dl, date: (b)(6) 2017, time: 2:51pm, non- fasting; result 2 :lomg/dl, date: (b)(6) 2017, time: 2:47pm, non- 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: 7145579
• Report Number: 1000113657-2017-02107
• Device Sequence Number: 966172
• Product Code: NBW
• UDI-Device Identifier: 00096295129489
• UDI-Public: (01)00096295129489
• 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: Replace
• Type of Report: Initial
• Report Date (Section B): 12/26/2017

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: 05/31/2019
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RT5054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2017
• Initial Report FDA Received Date: 12/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1