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

Model Number	METRIX AIR
Medical Device Problem Codes	High Test Results (2457); Low Test Results (2458)
Health Effect - Clinical Codes	Weakness (2145); Dizziness (2194); Shaking/Tremors (2515)
Date of Event	04/20/2018
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 and to ensure the customer's condition; customer stated that the replacement product is working to their satisfaction and they have not had any symptoms or medical intervention since the last call.
Event or Problem Description
Consumer reported complaint for lo and high blood glucose results.The expected fasting blood glucose test result range is 90 to 140mg/dl.The customer did report symptoms of feeling spacy, dizzy, shaky, and weak.(ealier this week).Medical attention is not reported as a result of the actual blood glucose results and reported symptoms.The product is stored by customer according to specification in the bedroom.During the call on (b)(6) 2018, a back to back blood test was performed non-fasting by the customer and produced test results of 172 and 176mg/dl using true metrix air meter.The test strip lot manufacturer's expiration date is 05/31/2019 and open vial date is (b)(6) 2018.The meter memory was reviewed for previous test result history: result 1:57mg/dl date: (b)(6) 2018 time:3:48pm n/fasting; result 2:64mg/dl date: (b)(6) 2018 time:3:42pm n/fasting; result 3:302mg/dl date: (b)(6) 2018 time:10:57pm fasting; result 4:264mg/dl date: (b)(6) 2018 time:10:57pm fasting; result 5:65mg/dl date:(b)(6) 2018 time:7:00pm n/fasting; result 6:lo date: (b)(6) 2018 time: 6:59pm fasting; customer states he has had hypoglycemic events this week due to the meter readings.Per his sliding scale customer is to take 10 1/2 units but states he took 6 1/2 units of insulin instead, which is less than what the sliding scale asked for.Customer states he also ate at the time and two hours later, he began to feel spacy, dizzy, shaky, and weak.Customer tested again and meter read 57mg/dl and 64mg/dl non-fasting.Customer states he took two glucose tablets, 1/2 bean burrito, imitation crabsticks, and 30-45mins later he began to feel better again.Customer feels well and is no longer experiencing symptoms at time of call.No medical attention was required.

• 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: 7514316
• Report Number: 1000113657-2018-00550
• Device Sequence Number: 1385786
• Product Code: NBW
• UDI-Device Identifier: 00311917173894
• UDI-Public: (01)00311917173894
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 05/15/2018

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: MU2700
• 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: 04/20/2018
• Initial Report FDA Received Date: 05/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1