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	Blurred Vision (2137)
Date of Event	09/17/2018
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-20-user's test strip had poor storage(kitchen).Test strip udi# (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.
Event or Problem Description
Consumer reported complaint for high blood glucose results.Customer is concerned with results obtained of 166mg/dl.The expected fasting blood glucose test result range is 95-110mg/dl.Customer did report symptoms of blurry vision.Medical attention is not reported as a result of the actual blood glucose results and reported symptoms.During the call on a blood test was performed fasting by the customer and produced test results of 166mg/dl using true metrix meter.The product is not stored by customer according to specification in the kitchen.The test strip lot manufacturer's expiration date is 08/15/2019 and open vial date is (b)(6) 2018.The meter memory was not reviewed for previous test result history.Customer could not pull up the readings.

• 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: 7958366
• Report Number: 1000113657-2018-01023
• Device Sequence Number: 1301645
• Product Code: NBW
• UDI-Device Identifier: 00011822445610
• UDI-Public: (01)00011822445610
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/11/2018

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: MV2786
• 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: 09/17/2018
• Initial Report FDA Received Date: 10/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1