MAUDE Adverse Event Report: TRIVIDIA HEALTH, INC. TRUEMETRIX; BLOOD GLUCOSE SYSTEM

Model Number	TRUEMETRIX
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-58-user had an inaccurate reference: self: the person is using themselves as the reference or how they feel at the time they run the blood test.Test strip udi# (b)(4).
Event or Problem Description
Consumer initially reported complaint for high control glucose test results.After troubleshooting, customer also reported complaint for high blood glucose test results.The customer is concerned with test results from results obtained of 252, 283 and 205 mg/dl.The customer's expected fasting blood glucose test result range is 140 - 160 mg/dl.The customer feels well and did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results.During the call on (b)(6) 2018, a back to back blood test was performed by the customer fasting and produced test results of 243 mg/dl and 227 mg/dl using truemetrix meter.The product is stored according to specification in the office.The test strip lot manufacturer's expiration date is 01/31/2019 and open vial date is (b)(6) 2017.The meter memory was reviewed for previous test result history: (b)(6).Customer is primarily concerned with the 252 mg/dl, 283 mg/dl, and 205 mg/dl readings because they are way higher than her normal range.Customer had also taken a control test before and got a 92 mg/dl and it did not read within the range of the control solution level 2, which was 98-132.

• Brand Name: TRUEMETRIX
• Common Device Name: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 7273219
• Report Number: 1000113657-2018-00196
• Device Sequence Number: 18873027
• Product Code: NBW
• UDI-Device Identifier: 10612479210261
• UDI-Public: (01)10612479210261
• Combination Product (Y/N): N
• Initial Reporter State: UT
• PMA/510(K) Number: K140100
• 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): 02/15/2018

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: 01/31/2019
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MU2568
• 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: 01/24/2018
• Initial Report FDA Received Date: 02/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1