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 Codes	Urinary Frequency / Polyuria (2275); Polydipsia (2604); No Code Available (3191)
Date of Event	12/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) (b)(4).Product not returned for evaluation.Customer declined replacement product at this time.Complaint resolved by training during the time of the call.Product is working as designed.Most likely underlying root cause: mlc-21- improper technique of obtaining or applying blood sample.Test strip (b)(4).Note: manufacturer contacted customer on (b)(6) 2017 in a follow-up call in order to ensure the customer's condition since the initial call; customer's condition had improved and he did not currently have any diabetic symptoms.The customer stated he had gone to the er on (b)(6) 2017.The customer's blood glucose test result when at the hospital was 350 mg/dl fasting.The diagnosis was high blood sugar and metformin was administered to customer.The customer left the er on (b)(6) 2017.There were no new medications or healthcare program suggested by healthcare professional.Customer stated that he just found out that he is a diabetic and he did not believe the meter was inaccurate and declined a replacement.
Event or Problem Description
Consumer reported complaint for e-0: invalid hematocrit.The e-0 occurred when the blood sample was absorbed.During the call on (b)(6) 2017, a blood test was performed by the customer fasting and produced test result of 421 mg/dl using truemetrix air meter.The customer's expected blood glucose test result range was undisclosed.At the time of the call the customer reported symptoms of dry mouth, increased thirst and increased urination.Customer stated he would seek medical intervention.The product storage was undisclosed.The test strip lot manufacturer's expiration date is 03/31/2019 and open vial date is (b)(6) 2017.The meter memory was not reviewed for previous test result history.

• 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: 7163828
• Report Number: 1000113657-2018-00016
• Device Sequence Number: 19327604
• Product Code: NBW
• UDI-Device Identifier: 00311917173894
• UDI-Public: (01)00311917173894
• Combination Product (Y/N): N
• 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): 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/31/2019
• Device Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MU2639
• 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: 12/11/2017
• Initial Report FDA Received Date: 01/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1