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	02/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Customer declined replacement.Customer needs only control solution to test ther device.Most likely underlying root cause: mlc-20-user's test strip had poor storage (kitchen).(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 product is working to their satisfaction and they have not had any medical intervention since the last call.Complaint resolved.
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with tests results from results obtained of 246 and 272 mg/dl.The customer's expected fasting blood glucose test result range is 125 - 160 mg/dl.The customer feels well and did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results.During the call on (b)(6) 018, a back to back blood test was not performed by the customer.The product is not stored according to specification and is stored in the kitchen.The test strip lot manufacturer's expiration date is 10/31/2018 and open vial date at time of call is three weeks.The meter memory was reviewed for previous test result history: result 1 :158mg/dl date (b)(6) 2018 time:6:50pm fasting, result 2 :246mg/dl date: (b)(6) 2018 time:2:50 pm fasting, result 3 :272mg/dl date: (b)(6) 2018 time:10:24am fasting, customer states that his meter started testing high within the last few weeks.Customer compared the results based on how he felt at the time of testing.The results of concerned are 246 and 272mg/dl fasting.Expected range is 125-160mg/dl fasting.Customer states that he does not want his meter replaced, he only wants to order control solutions to test if the meter is defective.

• 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: 7302756
• Report Number: 1000113657-2018-00237
• Device Sequence Number: 2378676
• Product Code: NBW
• UDI-Device Identifier: 00041220009169
• UDI-Public: (01)00041220009169
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/28/2018

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 Expiration Date: 10/31/2018
• Device Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MU2452
• 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: 02/01/2018
• Initial Report FDA Received Date: 02/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1