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	09/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) (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 (b)(4).
Event or Problem Description
Consumer reported complaint for high blood glucose results.The customer is concerned with the result of 136 and 460 mg/dl.The expected fasting blood glucose test result range is 92 to 120 mg/dl.The customer did not report symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product is stored by customer according to specification.During the call on (b)(6) 2017, a back to back blood test was performed fasting by the customer and produced test results of 95 and 86 mg/dl using true metrix meter.The test strip lot manufacturer's expiration date is 11/15/2018 and open vial date is (b)(6) 2017.The meter memory was reviewed for previous test result history: 136 mg/dl (b)(6) 2017 11:35 am fasting: yes, 2:460 mg/dl (b)(6) 2017 09:47 am fasting: yes.Customer called regarding results that she is getting from her meter.Customer states that results are erratic when she took a back to back blood test.Customer is feeling well at this time and is not having any symptoms related to her diabetes.Had customer perform a back to back blood test with results of 95 and 86 mg/dl fasting.

• 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: 6949348
• Report Number: 1000113657-2017-01805
• Device Sequence Number: 745459
• Product Code: NBW
• UDI-Device Identifier: 00713733069816
• UDI-Public: (01)00713733069816
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 10/13/2017

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: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MU2457
• 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: 09/20/2017
• Initial Report FDA Received Date: 10/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1