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	Hyperglycemia (1905)
Date of Event	08/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned meter and returned test strips evaluated with no defects found.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.Test strip udi# ((b)(4).Note: manufacturer contacted customer on (b)(4) 2018 in a follow-up call to ensure that the replacement products resolved the initial concern; on (b)(6) 2018 customer went to dr.Her blood sugar was high and so she went to the doctor.Result at home was 365mg/dl and it was a fasting test.Customer had no symptoms but felt the result was high.An hour later she went to the dr.Office it was 456mg/dl but it was a non -fasting test.Customer was given new medication.Customer left dr.Office same day and did seek any further medical assistance.The customer is feeling well now.Customer satisfied with the replacement product.
Event or Problem Description
Consumer reported complaint for high blood glucose results.The customer is concerned with all of the results obtained.The expected fasting blood glucose test result range is unknown.The customer feels well and did not report symptoms.Medical attention is reported as a result of the actual blood glucose results.The product is stored by customer according to specification in the living room.During the call on (b)(6) 2018, a back to back blood test was performed fasting by the customer and produced test results of 447 and 359mg/dl using true metrix air meter.The test strip lot manufacturer's expiration date is 07/31/2019 and open vial date is (b)(6) 2018.The meter memory was reviewed for previous test result history: (date/time not stored correctly): (b)(6).Customer calling in stating the meter is reading erratic readings.Customer also states meter is reading high readings in the morning.Customer is testing fasting.However, customer is not doing the proper back to back testing.Customer is not sure what expected range is.Customer last a1c was in feb at 9%.Customer did have recent changes in medication.Oral diabetic meds were increased.However, customer states reading are still high.Customer educated on proper back to back testing and readings were erratic.

• 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: 7861600
• Report Number: 1000113657-2018-00937
• Device Sequence Number: 1337382
• Product Code: NBW
• UDI-Device Identifier: 00041415072787
• UDI-Public: (01)00041415072787
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/10/2018

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: MV2780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 09/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1