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	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned meter evaluated with no defect found.Test strips not returned for evaluation.Most likely underlying root cause: mlc-18- user has high glucose value test strip udi# (b)(4).Manufacturer contacted customer on (b)(6) 2018 in a follow-up call in order to ensure that the replacement products resolved the initial concern; customer stated that the replacement product is working to their satisfaction and they have not had any medical intervention since the last call.
Event or Problem Description
Consumer reported complaint for hi blood glucose results.Son is calling on behalf of the customer.The expected fasting blood glucose test result range is undisclosed.The customer feels well and did not report symptoms.Medical attention is reported as a result of the actual blood glucose results.The product storage location is undisclosed.During the call on (b)(6) 2018, a blood test was performed non-fasting by the customer and produced test results of hi using true metrix meter.The test strip lot manufacturer's expiration date is 06/14/2019 and open vial date is (b)(6) 2018.The meter memory was not reviewed for previous test result history.Caller wanted to know what a e-5 meant because she tested about 7 times and got a reading of e-5 between 2 vials of strips both of the same lot number.Caller was told that error could mean a test strip error or that she is exceeding 600 mg/dl.The customer stated that she did not feel any hyperglycemic symptoms and that she felt fine.Son was asked to have her test again with a new vial of strips and she got a reading of e-5 again (same lot number as the first.Son was asked if there were any other vials in the home with a different lot # and he found lot#mu2710 which was sealed at the time of this test.Customer tested again and the reading was hi.Customer was told to seek medical attention despite not feeling symptomatic.I advised the son to call her doctor and to not waste any more time despite feeling better.The user stated that the doctor gave her some "liquid" a while back and that she has not used it in a while.Son was informed that the meter & strips would be replaced and that i would be sending control solution as well to test the meter's accuracy.Caller informed that the old one would have to be sent back for investigation.Upon calling as a follow up, son stated that the doctor recommended she take her insulin (novolog) and she took 3 units.Doctor stated to test again in a couple of hours and see if the result has gone down and if not to call back.

• 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: 7448317
• Report Number: 1000113657-2018-00461
• Device Sequence Number: 16170345
• Product Code: NBW
• UDI-Device Identifier: 00096295126600
• UDI-Public: (01)00096295126600
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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: Replace
• 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: MU2710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2018
• 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