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 Codes	Headache (1880); Nausea (1970)
Date of Event	03/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-18- user has high glucose value (b)(4).Manufacturer contacted customer on (b)(6) 2018 in follow-up calls in order to ensure the customer's condition since the initial call; customer's condition has improved.There was no medical intervention at a hospital however; customer had his insulin dosage adjusted by his doctor over the phone.Customer is at school and father states he is not aware of today's results but states stepson is doing better.Customer is satisfied with the replacement product.
Event or Problem Description
Consumer reported complaint for hi blood glucose results.Stepfather is calling on behalf of the customer.The expected fasting blood glucose test result range is 80-180mg/dl.The customer did report symptoms of headache and nausea.Medical attention is not reported as a result of the actual blood glucose results and reported symptoms.The product is not stored by customer according to specification in the kitchen.During the call on (b)(6) 2018, a blood test was performed non-fasting by the customer and produced test results of hi using true metrix air meter.The test strip lot manufacturer's expiration date is 11/25/2018 and open vial date is a few weeks ago.The meter memory was reviewed for previous test result history: (date/time not stored correctly) result 1 : hi display date: (b)(6) 2018 time:10:11am fasting; result 2 :372mg/dl date: (b)(6) 2018 time:8:33am fasting; result 3 :447mg/dl date: (b)(6) 2018 time:7:48pm fasting; result 4 :280mg/dl date: (b)(6) 2018 time:4:41pm fasting; result 5 :523mg/dl date: (b)(6) 2018 time:2:36pm fasting.Customer's stepdad states the meter read e-5 and hi display today while customer was at school.Stepdad wanted to know the difference between hi display and e-5 was his reason for calling.Customer was brought home early from school.Stepdad states customer will not seek medical attention at this time but has taken insulin and drinking water and resting at this time.Customer denies the need for medical attention at the time of call and has a headache and nausea as signs and symptoms of hyperglycemia at the time of call.

• 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: 7373517
• Report Number: 1000113657-2018-00362
• Device Sequence Number: 13726139
• Product Code: NBW
• UDI-Device Identifier: 00011822590051
• UDI-Public: (01)00011822590051
• Combination Product (Y/N): N
• Initial Reporter State: OR
• PMA/510(K) Number: K150052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/27/2018

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: MU2483
• 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: 03/02/2018
• Initial Report FDA Received Date: 03/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1