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	04/19/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned meter and returned test strips evaluated with no defects found.Most likely underlying root cause: user's test strip had poor fill.Teststrip udi# (b)(4).Based on review with fda on 06/21/2017, we verified the agency's interpretation of the act and submit this medwatch report based on the nature of the complaint for this recalled lot.Fda-assigned recall event id 74805.
Event or Problem Description
Consumer reported complaint for low blood glucose test results.Customer believed her results were inconsistent because she felt they were low.The customer's expected fasting blood glucose test result range is 70-110mg/dl.Even though her results have been within her expected results customer preferred meter being replaced.Ran blood test with me fasting 95mg/dl.Customer has not needed medical attention and is no experiencing any symptoms of low blood glucose results.The product is stored according to specification.The meter memory was reviewed for previous test result history: a 95mg/dl, (b)(6)2016 12:32:00 pm, fasting:yes.A 84mg/dl, (b)(6)2016 12:44:00 pm, fasting:yes.A 81mg/dl, (b)(6)2016 01:03:00 pm, fasting:yes.A 96mg/dl, (b)(6)2016 08:06:00 am, fasting:yes.A 76mg/dl, (b)(6)2016 07:58:00 am, fasting:yes.Memory concerns:customer is concerned about her results being low even though results we viewed from the memory are within her expected results of 70-110mg/dl.

• 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: 6681567
• Report Number: 1000113657-2017-01167
• Device Sequence Number: 19232925
• Product Code: NBW
• UDI-Device Identifier: 00021292001797
• UDI-Public: (01)00021292001797
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 06/30/2017

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: 10/31/2017
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RS4680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2016
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2017
• Initial Report FDA Received Date: 06/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1