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	02/24/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned meter evaluated with no defect found.Test strips not returned for evaluation.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.Strip expiration date is 10/15/2017 and strip open date is (b)(6) 2016.Reviewed meter memory: 82mg/dl (b)(6) 2016 08:20:00 am fasting: no; 99mg/dl (b)(6) 2016 11:40:00 pm fasting: no; 99mg/dl (b)(6) 2016 12:12:00 am fasting: no; 163mg/dl (b)(6) 2016 03:18:00 pm fasting: no; 96mg/dl (b)(6) 2016 08:48:00 am fasting: no.Memory concerns: concern with 82 on (b)(6) 2016 08:20:00 am.Customer called concerned that his meter was reading his blood sugar of 82 mg/dl-15 minutes after eating.I confirmed that he was feeling fine (asymptomatic), there was no need any medical intervention at the time of the call or the result in question.He hadn't made any changes to his diet or medication (metformin).His expected blood sugar levels should be between 115-120 (fasting).I also verified that he had properly storing his supplies on the living room table at room temperature.I had him run a back to back test, results read 113 and 104 mg/dl (about a half hour after eating).He stated he normally test after eating as recommended by his doctor.

• 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: 6698798
• Report Number: 1000113657-2017-01232
• Device Sequence Number: 1735794
• Product Code: NBW
• UDI-Device Identifier: 00021292001971
• UDI-Public: (01)00021292001971
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: 10/15/2017
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RS4653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2016
• 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