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

Model Number	TFOCUS
Medical Device Problem Codes	Unable to Obtain Readings (1516); Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) internal report: # (b)(4).Product not returned for evaluation.Most likely underlying root cause: mlc-20 - user's test strip had poor storage.Test strip udi #: (b)(4).Note: manufacturer contacted customer to ensure that the replacement products resolved the initial concern - able to establish contact with customer who indicated that is comfortable with results from the replacement meter.
Event or Problem Description
Consumer reported complaint for lo display.Customer states that he recently got the meter and is getting a lot of errors.Customer he run a blood test and got 103mg/dl 3 times.Customer have only been using the meter for 3-4 days.The expected fasting blood glucose test result range is unknown.The customer did not report symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product is not stored according to specification in the kitchen.The test strip lot manufacturer's expiration date is 08/29/2020 and open vial date is (b)(6) 2019.The meter memory was reviewed for previous test result history: (b)(6).

• Brand Name: TFOCUS
• Common Device Name: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 8701886
• Report Number: 1000113657-2019-00619
• Device Sequence Number: 2260714
• Product Code: NBW
• UDI-Device Identifier: 00021292007744
• UDI-Public: (01)00021292007744
• Combination Product (Y/N): N
• Initial Reporter State: VT
• PMA/510(K) Number: K131013
• 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): 06/14/2019

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: TFOCUS
• Device Lot Number: NV1000
• 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: 05/20/2019
• Initial Report FDA Received Date: 06/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1