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	Fatigue (1849); Blurred Vision (2137); Dizziness (2194)
Date of Event	05/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not returned for evaluation.Customer unable to answer any further questions due to symptoms.No address provided by customer.Most likely underlying root cause: mlc-18- user has high glucose value test strip udi# (b)(4).Note: 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.Unable to send product notification letter to customer to contact customer care.
Event or Problem Description
Consumer reported complaint for e-5 accompanied by symptoms.The expected fasting blood glucose test result range is undisclosed.The customer did report symptoms of fatigue, blurred vision, feeling dizzy.Medical attention is not reported as a result of the actual blood glucose results and reported symptoms.Product storage location is undisclosed.During the call on (b)(6) 2018 blood test was not performed.The test strip lot manufacturer's expiration date is 07/31/2019 and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.Customer was unable to answer any further questions due to symptoms.

• 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: 7605616
• Report Number: 1000113657-2018-00652
• Device Sequence Number: 16567734
• Product Code: NBW
• UDI-Device Identifier: 00011822590051
• UDI-Public: (01)00011822590051
• 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): 06/15/2018

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: MV2776
• 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: 05/23/2018
• Initial Report FDA Received Date: 06/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1