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	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-58-user had an inaccurate reference: self: the person is using themselves as the reference or how they feel at the time they run the blood test.(b)(4).Manufacturer contacted customer on (b)(6) 2018 in a follow-up call in order to ensure that the replacement products resolved the initial concern; customer stated that the replacement product is working to their satisfaction and they have not had any medical intervention since the last call.
Event or Problem Description
Consumer reported complaint for high blood glucose results.The customer is concerned results obtained of 331mg/dl.The expected fasting blood glucose test result range is 100-140mg/dl.The customer feels well and did not report symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product is stored by customer according to specification in the livingroom.During the call on (b)(6) 2018, a back to back blood test was performed fasting by the customer and produced test results of 255 and 220mg/dl using true metrix air meter.The test strip lot manufacturer's expiration date is 11/30/2018 and open vial date is (b)(6) 2017.The meter memory was reviewed for previous test result history: (date/time not stored correctly) result 1 :237mg/dl date: (b)(6) 2018 time:8:15am fasting, result 2 :302mg/dl date: (b)(6) 2018 time:8:14am fasting, result 3 :331mg/dl date: (b)(6) 2018 time:9:45pm fasting, result 4 :93mg/dl date: (b)(6) 2018 time:1:03pm fasting, result 5 :150mg/dl date: (b)(6) 2018 time:7:16am fasting, customer called in states the meter is reading high.Customer states the meter read 331mg/dl fasting.Customer states his normal fasting range is 100-140mg/dl fasting.Customer denies the need for medical attention at the time of call and denies signs and symptoms of hyperglycemia at the time of call.Customer states he is not concerned with erratic results but his main concern is due to high readings.

• 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: 7272927
• Report Number: 1000113657-2018-00194
• Device Sequence Number: 19093794
• Product Code: NBW
• UDI-Device Identifier: 00011822590051
• UDI-Public: (01)00011822590051
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 02/15/2018

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: MU2496
• 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: 01/23/2018
• Initial Report FDA Received Date: 02/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1