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	12/21/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) (b)(4).Returned meter and returned test strips evaluated with no defects found.Most likely underlying root cause of malfunction: user's test strip had poor storage.Sed 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.(b)(4).
Event or Problem Description
Consumer reported complaint for low results.Customer reported no symptoms, and does not need medical attention.Strip expiration date is 11/28/2017 and strip open date is week of (b)(6) 2015.Reviewed meter memory: (b)(6).Customer is calling with a complaint his true track meter was giving him results lower than that of his expected fasting range of 110-120 mg/dl.Customer was concerned when he obtained a result 85 mg/dl on (b)(6) 2015 at 10:02 am.Customer also was concerned as his hgba1c was 7.6 and his lab work gave a blood glucose level 132 mg/dl and when he tested 1 hour earlier the meter gave him a result of 106 mg/dl.Customer stated he had no symptoms of hypo/hyperglycemia noted at this time.Customer denies any changes in diet, exercise, medication, or health status.The meter and strips were not properly stored as they are kept in the kitchen of the home.

• 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: 6698768
• Report Number: 1000113657-2017-01250
• Device Sequence Number: 13854123
• Product Code: NBW
• UDI-Device Identifier: 00021292001971
• UDI-Public: (01)00021292001971
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 07/06/2017

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: 11/28/2017
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RS4692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2016
• 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: 07/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1