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

Model Number	TRUEMETRIX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Blurred Vision (2137)
Date of Event	03/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) (b)(4).Product not returned for evaluation.No replacement product needed at this time.Complaint resolved by training during the time of the call.Product is working as designed.Most likely underlying root cause: mlc-62-user had poor technique.Test strip (b)(4).Note: manufacturer contacted customer (several attempts) in a follow-up call in order to ensure the customer's condition since the initial call - unable to establish contact with the customer at this time.No address on file.Unable to send product letter to the customer.
Event or Problem Description
Consumer reported complaint for symptoms.The expected fasting blood glucose test result range is undisclosed.The customer did report symptoms of headache and blurry vision.Medical attention is not reported as a result of the actual blood glucose results and reported symptoms.The product storage location is undisclosed during the call on (b)(6) 2018, a blood test was performed fasting by the customer and produced test results of 159 mg/dl using true metrix meter.The test strip lot manufacturer's expiration date is 08/13/2019 and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.Customer called in for assistance running blood test.Customer states she has blurry vision and a headache.Had customer perform blood test: result: 159 mg/dl (fasting status not disclosed).Customer satisfied with the product after proper training during the time of the call.

• 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: 7446800
• Report Number: 1000113657-2018-00457
• Device Sequence Number: 18868918
• Product Code: NBW
• UDI-Device Identifier: 00052569138557
• UDI-Public: (01)00052569138557
• 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): 04/20/2018

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 Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MV2785
• 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: 03/28/2018
• Initial Report FDA Received Date: 04/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1