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	10/18/2018
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 strip vial returned with one strip only - unable to test.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).Note: manufacturer contacted customer on 11/2/2018 in a follow-up call to ensure that the replacement products resolved the initial concern; customer stated that the replacement product is working to their satisfaction and they have not had any medical intervention or symptoms since the last call.
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with tests results from results obtained of 187, 206, 196, 168 and 169 mg/dl.The customer's expected fasting blood glucose test result range is 90 - 140 mg/dl.Customer stated she noticed an increase in the results for the past few months.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 back to back blood test was not performed by the customer.Product is stored according to specification in the bedroom.The test strip lot manufacturer's expiration date is 10/31/2018 and open vial date is (b)(6) 2018.The meter memory was reviewed for previous test result history: result 1:187 mg/dl date:(b)(6) 2018 time:1:00 am fasting.Result 2:206 mg/dl date:(b)(6) 2018 time:5:32 am fasting.Result 3:196 mg/dl date:(b)(6) 2018 time:1:00 am fasting.Result 4:168 mg/dl date:(b)(6) 2018 time:5:14 am fasting.Result 5:169 mg/dl date:(b)(6) 2018 time:5:27 am 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: 8065772
• Report Number: 1000113657-2018-01159
• Device Sequence Number: 2701852
• Product Code: NBW
• UDI-Device Identifier: 10612479210261
• UDI-Public: (01)10612479210261
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 11/13/2018

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: 10/31/2018
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MU2451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 11/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1