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	01/12/2016
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 of malfunction: user's test strip had poor fill.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.(b)(4).
Event or Problem Description
Consumer reported complaint for low results.Customer reported no symptoms, and does not need medical attention.Customer's expected results are 100-125mg/dl- fasting.Strip expiration date is 11/30/2017 and strip open date is (b)(6) 2015.Strip storage is in bedroom.Customer declined a back to back blood test reviewed meter memory: 91mg/dl (b)(6) 2016 08:00:00 am fasting: yes; 99mg/dl (b)(6) 2016 08:01:00 am fasting: yes; 101mg/dl (b)(6) 2016 08:00:00 am fasting: yes; 110mg/dl (b)(6) 2015 10:44:00 pm fasting: yes; 112mg/dl (b)(6) 2016 10:44:00 pm fasting: yes.Memory concerns: customer is concerned with all of the readings in the meters memory customer called concerned their meter is registering low results because today (b)(6) 2015 at 10:43am fasting the customer tested their glucose and received a result of 101mg/dl the customer stated her glucose should have been around 120mg/dl, as she has been not eating right.The customer is currently taking metformin to manage diabetes.

• 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: 6689763
• Report Number: 1000113657-2017-01242
• Device Sequence Number: 45711
• Product Code: NBW
• UDI-Device Identifier: 00010939755339
• UDI-Public: (01)00010939755339
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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 Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RS4695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2016
• 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: 07/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1