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

Model Number	METRIX AIR
Medical Device Problem Codes	High Test Results (2457); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fatigue (1849); Polydipsia (2604)
Date of Event	10/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) internal report # (b)(4).Product not returned for evaluation.No replacement product needed at this time.Product is working as designed.Most likely underlying root cause: mlc-18: user has high glucose value.Test strip udi#(b)(4).Note: manufacturer contacted customer on (b)(4) 2018 in a follow-up call to ensure the customer's condition since the initial call; customer's condition has improved, and customer is no longer experiencing symptoms.On (b)(6) 2018 customer went to the hospital and was diagnosed with hyperglycemia (458mg/dl non-fasting).Customer was treated with insulin: novolog.Customer is now taking novolog, lantus and metformin again customer states she previously stopped taking her medications.Her novolog is now on a sliding scale.Customer was discharged the same day.Customer states she feels comfortable with product.
Event or Problem Description
Consumer reported complaint for hi display.The expected fasting blood glucose test result range is undisclosed.Customer did report symptoms of excessive thirst and fatigue.No medical attention reported at the time of the call as a result of the actual blood glucose results and reported symptoms.The product storage location is undisclosed.During the call on (b)(6) 2018, a back to back blood test was not performed.The test strip lot manufacturer's expiration date is 12/28/2018 and open vial date is undisclosed.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: 8037945
• Report Number: 1000113657-2018-01130
• Device Sequence Number: 1463715
• Product Code: NBW
• UDI-Device Identifier: 00021292007010
• UDI-Public: (01)00021292007010
• 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): 11/05/2018

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 Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MU2531
• 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: 10/10/2018
• Initial Report FDA Received Date: 11/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1