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

Model Number	METRIX AIR
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not returned for evaluation.No replacement at this time.Only control solution send.Most likely underlying root cause, user applied blood to strip before inserting strip into meter.(b)(4).
Event or Problem Description
Consumer reported complaint for e-3 error: used test strip, test strip outside of vial too long, sample on top of test strip.The e-3 error occurred when the blood sample was absorbed.The customer's expected blood glucose test result range was undisclosed.During the call on (b)(6) 2017, the customer stated he had dry mouth.Customer stated he was not sure if his dry mouth was due to pills (herbs and vitamins) he usually takes or if it is related to his newly diagnosed diabetes.During the call on (b)(6) 2017, a back to back blood test was performed by the customer non-fasting and produced test results of e-3 using truemetrix air meter and e-3 using truemetrix air meter.The product is stored according to specification.The test strip lot manufacturer's expiration date is 06/30/2018 and open vial date is (b)(6) 2017.The meter memory was not reviewed for previous test result history.Customer is not sure if his dry mouth is due to pills (herbs and vitamins) he usually takes or if it is related to his newly diagnosed diabetes.Customer does not have any more strips and is going to the pharmacy to pick up.Advised customer to take meter with him and ask if they will test the meter or replace it for him.Advised customer that we can ship a replacement to the pharmacy.Unable to continue training or testing with customer for lack of strips or control solutions.

• Brand Name: METRIX AIR
• Common Device Name: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 6518262
• Report Number: 1000113657-2017-00728
• Device Sequence Number: 781547
• Product Code: NBW
• UDI-Device Identifier: 00010939742445
• UDI-Public: (01)00010939742445
• Combination Product (Y/N): N
• Initial Reporter State: WA
• PMA/510(K) Number: K150052
• 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): 04/25/2017

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: 06/30/2018
• Device Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MU2312
• 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: 03/31/2017
• Initial Report FDA Received Date: 04/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SECOND THERAPY