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	Headache (1880); Dizziness (2194); Polydipsia (2604)
Date of Event	01/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) (b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-103 - finger removed from strip before strip had sufficient time to fill test strip (b)(4).Note: manufacturer contacted customer on 1/19/2018 in a follow-up call in order to ensure the customer's condition since the initial call; customers condition has not improved since the time of the call.Customer was feeling shaky and vision very blurry.Customer did not seek any medical attention.Manufacturer contacted customer (several attempts) in a follow-up call in order to ensure the customer's condition since the initial call - unable to establish contact with the customer at this time.
Event or Problem Description
Consumer reported complaint for e-2 blood glucose results accompanied by symptoms.The customer is concerned with results obtained of e-2.The expected fasting blood glucose test result range is undisclosed.The customer did report symptoms of dizzy, headache, dry mouth.Medical attention is not reported as a result of the actual blood glucose results and reported symptoms.The product is stored by customer according to specification in the bedroom.During the call on (b)(6) 2018, a blood test was performed by the customer and produced test results of e-2 using true metrix air meter.The test strip lot manufacturer's expiration date is 03/31/2019 and open vial date is (b)(6) 2018.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: 7263007
• Report Number: 1000113657-2018-00159
• Device Sequence Number: 19023529
• Product Code: NBW
• UDI-Device Identifier: 00311917173894
• UDI-Public: (01)00311917173894
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Replace
• Type of Report: Initial
• Report Date (Section B): 02/12/2018

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: 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: 01/15/2018
• Initial Report FDA Received Date: 02/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1