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	09/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) internal report (b)(4).Product not returned for evaluation.No replacement product needed at this time.Product is working as designed.Most likely underlying root cause: mlc-18- user has high glucose value.(b)(4).
Event or Problem Description
Consumer reported complaint for hi blood glucose results.(b)(6), the customer's aide, is calling on behalf of the customer.The customer is concerned with the result of hi.The expected fasting blood glucose test result range is undisclosed.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 in the living area.During the call on (b)(6) 2017, a blood test was performed non-fasting by the customer and produced test results of hi using true meter meter.The test strip lot manufacturer's expiration date is (b)(6) 2018 and open vial date is (b)(6) 2017.The meter memory was reviewed for previous test result history.Result 1: hi (b)(6) 2017, 2:15pmtime:, non- fasting.Customer is not having any diabetic symptoms at this time.The aide just purchased this meter since the customer has a severe wound on his foot and wanted to check his blood sugar.She got a hi reading on the meter.I suggested she call the dr.To let them know about the meter reading hi and about the wound on his foot.She was already going to call the nurse since the customer has not taken his insulin today.She just started to use this meter today.

• 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: 6961214
• Report Number: 1000113657-2017-01831
• Device Sequence Number: 13758465
• Product Code: NBW
• UDI-Device Identifier: 00011822445610
• UDI-Public: (01)00011822445610
• Combination Product (Y/N): N
• PMA/510(K) Number: K140100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/19/2017

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: MU2490
• 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: 09/26/2017
• Initial Report FDA Received Date: 10/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1