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

Model Number	METRIX AIR
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	04/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause of malfunction: user's test strip had poor storage (remove the strips from the original vial and place them in the carrying case).Note: manufacturer contacted customer on 4/21/2017 in a follow-up call in order to ensure the customer's condition since the initial call; customer is no longer experiencing symptoms and no medical attention reported.
Event or Problem Description
Consumer reported complaint for e-3 accompanied by symptoms.The customer is concerned with tests results from e-3 results obtained and symptoms.The customer's expected fasting blood glucose test result range is undisclosed.The customer did report symptoms of feeling sick and having blurry vision.Medical attention is reported as a result of the actual blood glucose results and reported symptoms.The product is storage location is undisclosed.The test strip lot manufacturer's expiration date and open vial date are undisclosed.The meter memory was not reviewed for previous test result history.Customer states that he had to go the doctor yesterday because his diabetes was very high.Customer states that his glucose was up to 582mg/dl and the doctor increase his insulin.Customer is no longer experiencing 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: 6561842
• Report Number: 1000113657-2017-00832
• Device Sequence Number: 13679274
• Product Code: NBW
• UDI-Device Identifier: 00010939742445
• UDI-Public: (01)00010939742445
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/11/2017

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 Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: N/A
• 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: 04/19/2017
• Initial Report FDA Received Date: 05/11/2017
• 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