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 Codes	Fatigue (1849); Weakness (2145)
Date of Event	08/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not returned for evaluation.No replacement product needed at this time.Most likely underlying root cause: mlc-134-user has low glucose value test strip udi# (b)(4).Note: at call back on (b)(6) 2018, the customer's condition had improved and he did not currently have any diabetic symptoms.Customer stated he had contacted his doctor but that the doctor did not return his call.Customer stated he had also gone to the doctor's office but was not able to see the doctor.Customer stated that when he had obtained the result of 72 mg/dl he was feeling weak for about two days.Customer stated since then he has been getting results in the 500s and now he is getting results in the 300s.Customer stated that he is now taking a generic insulin.Customer has only been using the truetrack meter for about 3 weeks.Customer stated that for the past 6 months his blood glucose results vary every day, and that his blood sugar can go from high to low.Customer stated that if his blood sugar gets very low he does have symptoms but if it is over 500 mg/dl he does not have any symptoms.Customer stated that he does not know what his normal glucose range should be.Customer is continuing to use the truetrack meter.
Event or Problem Description
Consumer reported complaint for low blood glucose test results.Customer had called to perform blood test, reference internal report # (b)(4), and had obtained a result of 72 mg/dl and believed it to be low.Customer did not know his expected blood glucose test result range.At the time of the call the customer reported feeling tired and stated that he has been going to bed early.Customer was going to call his doctor.The product storage was not disclosed.The test strip lot manufacturer's expiration date is 04/30/2019 and open vial date was undisclosed.Test strips are not impacted by recall.The meter memory was not reviewed for previous test result history.

• 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: 7903284
• Report Number: 1000113657-2018-00968
• Device Sequence Number: 1434317
• Product Code: NBW
• UDI-Device Identifier: 00021292001018
• UDI-Public: (01)00021292001018
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 09/24/2018

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: 04/30/2019
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RT5025
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2018
• Initial Report FDA Received Date: 09/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1