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

Model Number	TRUEMETRIX
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	06/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not returned for evaluation.No replacement product needed at this time.Customer obtain a bg reading at the time of the call.Customer will get a prescription for a different meter due to his condition.Most likely underlying root cause: mlc-78- user hematocrit low.(b)(4).Manufacturer contacted customer on (b)(6) 2018 in a follow-up call to ensure the customer's condition since the initial call; customer's condition had improved and he did not currently have any diabetic symptoms.Due to e-0 error and being unable to obtain a blood glucose test result, the customer had gone to the hospital on (b)(6) 2018 to get a blood test.Caller did not know customer's blood glucose test result when at the hospital.Customer left the hospital on (b)(6) 2018 with a prescription for a new meter.No additional blood tests were performed using the truemetrix meter.
Event or Problem Description
Consumer reported complaint for e-0 error: invalid hematocrit.Friend is calling on behalf of the customer.The e-0 error occurred when the blood sample was absorbed and with multiple test strips.At the time of the call the customer stated that he had blurry vision; customer denied the need for medical attention at the time of the call.During the call on (b)(6) 2018, a blood test was performed by the customer and produced test result of 131mg/dl using truemetrix meter.The customer's expected blood glucose test result range was undisclosed.The product storage was undisclosed.The test strip lot manufacturer's expiration date is 09/15/2018 and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.

• 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: 7685957
• Report Number: 1000113657-2018-00752
• Device Sequence Number: 19181935
• Product Code: NBW
• UDI-Device Identifier: 10612479210261
• UDI-Public: (01)10612479210261
• Combination Product (Y/N): N
• Initial Reporter State: TX
• PMA/510(K) Number: K140100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/13/2018

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: 09/15/2018
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MU2388
• 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: 06/19/2018
• Initial Report FDA Received Date: 07/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1