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	12/04/2015
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 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.Recall #fda-assigned recall event id 74805.(b)(4).
Event or Problem Description
Consumer reported complaint for low results.Customer reported no symptoms, and does not need medical attention.Strip storage is in the kitchen.Customer's meter is giving about 60 points lower.Customer states that he compares the meter to two different dr.Office meters.Customer states that his last a1c was 7.8-8.2.He is getting an average of 140mg/dl on the meter.Customer is legally blind and is unable to see the serial # and the strips lot #.Customer states that he is not sure what his expected range is varies.But his a1c test is showing in the 200mg/dl range.Customer is taking invocana.Customer states that he was testing once a day, but he has not used the meter for about a month now.

• 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: 6696582
• Report Number: 1000113657-2017-01274
• Device Sequence Number: 19080719
• Product Code: NBW
• UDI-Device Identifier: 00052569132463
• UDI-Public: (01)00052569132463
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 07/07/2017

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: RS4677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2015
• 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: 07/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1