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	08/22/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report # (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.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.Test strip udi: (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 11/30/2017 and strip open date is (b)(6) 2015.Strip storage is not correct.Reviewed meter memory: the 96mg/dl (b)(6) 2015 10:38:00 am fasting:yes, the 103mg/dl (b)(6) 2015 03:22:00 am fasting:yes, the 108mg/dl (b)(6) 2015 01:22:00 am fasting:yes, the 83mg/dl (b)(6) 2015 07:33:00 am fasting:yes, the 92mg/dl (b)(6) 2015 07:08:00 am fasting:yes.Customer test strips match the code chip.

• 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: 6705578
• Report Number: 1000113657-2017-01413
• Device Sequence Number: 1540902
• Product Code: NBW
• UDI-Device Identifier: 00096295129489
• UDI-Public: (01)00096295129489
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/12/2017

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: RS4698
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2015
• 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: 07/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1