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

Model Number	TRUEMETRIX
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not returned for evaluation.Customer declined replacement product at this time.Customer satisfied after control test at the time of the call.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 (several attempts) in a follow-up call to ensure that the initial concern was resolved- unable to establish contact with the customer at this time.Unable to send product letter.No address for the customer on file.
Event or Problem Description
Consumer reported complaint for low blood glucose test results.The customer is concerned with tests results from results obtained of 72, 85 and 78 mg/dl.The customer's expected fasting blood glucose test result range is 100 - 120 mg/dl.The customer is using the correct testing technique.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, a 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 02/16/2020, and open vial date is (b)(6) 2018.The meter memory was reviewed for previous test result history: (b)(6).Customer called in concerned about low results.Advised customer of meter variance.Customer is storing strips properly and is using the correct technique.Ran control solution test and results are within range.Customer will continue to use meter.

• 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: 8252657
• Report Number: 1000113657-2019-00038
• Device Sequence Number: 2701675
• Product Code: NBW
• UDI-Device Identifier: 00021292007041
• UDI-Public: (01)00021292007041
• 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): 01/16/2019

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 Expiration Date: 02/16/2020
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MV2889
• 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: 12/20/2018
• Initial Report FDA Received Date: 01/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1