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	09/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) internal report # (b)(4) returned meter evaluated with no defect found.Test strips not returned for evaluation.Most likely underlying root cause: mlc-56- user had an inaccurate reference: lab results: the end user is comparing results obtained from trividias's bgm system to the results from the laboratory.(b)(4).
Event or Problem Description
Consumer reported complaint for low blood glucose test results.Daughter is calling on behalf of the customer.The customer is concerned with test results from results obtained of 68, 64 and 63 mg/dl.The customer's expected fasting blood glucose test result range is 90 - 130 mg/dl.Customer stated that she was not having any symptoms when she got the low results.At the time of the call the customer felt well and did not report any symptoms.Daughter stated she had called the doctor's office to get advice as to why the results were low; daughter scheduled an appointment for customer to go in to see the doctor because of the low results.Customer went to the doctor's office on (b)(6) 2017.Customer took the truetrack meter to the doctor to compare and is getting about 40 mg/dl difference (comparison results were not provided).While at the doctor's office, the doctor performed a blood test and obtained a result of 128 mg/dl fasting and then performed an a1c test and the result was 7.5.No new medications were prescribed by the doctor.The doctor advised the customer that her glucose is not low.Customer purchased another truetrack meter at the pharmacy.During the call on (b)(6)2017, a back to back blood test was not performed by the customer.The product is stored according to specification.The test strip lot manufacturer's expiration date is 01/25/2019 and open vial date at time of call is one month.The meter is not coded properly.The meter memory was reviewed for previous test result history: 1:110mg/dl (b)(6) 2017 01:11 pm fasting :yes.2:90mg/dl (b)(6) 2017 08:21 am fasting: yes.3:68mg/dl (b)(6) 2017 10:46 pm fasting :yes.4:92mg/dl (b)(6) 2017 09:28 am fasting: yes.5:81mg/dl (b)(6) 2017 06:07 pm fasting: yes.Memory concerns : 68mg/dl fasting.

• 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: 6912097
• Report Number: 1000113657-2017-01773
• Device Sequence Number: 108304
• Product Code: NBW
• UDI-Device Identifier: 00011822577540
• UDI-Public: (01)00011822577540
• 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: other
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 10/03/2017

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: 01/25/2019
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RT4953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2017
• Initial Report FDA Received Date: 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1