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

Model Number	METRIX AIR
Medical Device Problem Codes	Unable to Obtain Readings (1516); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Urinary Frequency / Polyuria (2275); Polydipsia (2604)
Date of Event	11/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not returned for evaluation.No replacement product needed at this time.Most likely underlying root cause: mlc-62-user had poor technique.(b)(4).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 is no longer experiencing symptoms.Customer states he went to a local clinic on (b)(6) 2018 and was given oral medication (metformin).His blood glucose reading was 313 mg/dl non-fasting and he was released on (b)(6) 2018.
Event or Problem Description
Consumer reported complaint for dashes displayed accompanied by symptoms.The expected fasting blood glucose test result range is undisclosed.The customer did report symptoms of excessive thirst, blurry vision, feels tired, and has frequent urination.Medical attention is reported as a result of the actual blood glucose results and reported symptoms.The product storage location is undisclosed is stored by customer according to specification in the location.During the call on (b)(6) 2018, a blood test was performed fasting by the customer and produced test results of 232 mg/dl using true metrix air meter.The test strip lot manufacturer's expiration date is 02/29/2020 and open vial date is unknown.The meter memory was not reviewed for previous test result history.Customer called in states the meter only displays three dashes on the screen.Asked customer to turn the meter on and states he sees three dashes.Walked customer through a proper testing technique and meter read 232 mg/dl fasting.Customer also states his tongue is white.Customer was at the local (b)(6) and only spoke spanish.Spoke with pharmacist and informed her of the symptoms and the white tongue and that he was instructed to call 911 or to go to his doctor's office.

• 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: 8110848
• Report Number: 1000113657-2018-01206
• Device Sequence Number: 13883571
• 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): 11/28/2018

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: MV2908
• 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: 11/05/2018
• Initial Report FDA Received Date: 11/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1