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	05/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned meter evaluated with no defect found.Test strips not returned for evaluation.Most likely underlying root cause of malfunction: user's test strip had poor storage (kitchen).(b)(4).
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with test results from results obtained of 151 mg/dl.Customer stated that she dropped the meter a few times and the meter has been giving high blood results for about a month.The customer's expected fasting blood glucose test result is 109 mg/dl.Customer stated she only tests once a day (fasting).The customer feels well and did not report any symptoms.Customer stated that she made an appointment to see the doctor because of the high blood results the meter was giving.Customer stated that she was told that her stress level was high and that might be a reason her results were high; no new medication was given.Customer had made the appointment because of the high blood results.During the call on (b)(6) 2017, 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 07/31/2018 and open vial date is (b)(6) 2017.The meter memory was reviewed for previous test result history (date/time not set): (b)(6).Memory concerns: customer is concern with all these results.

• 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: 6589245
• Report Number: 1000113657-2017-00898
• Device Sequence Number: 1278734
• Product Code: NBW
• UDI-Device Identifier: 00050428354766
• UDI-Public: (01)00050428354766
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/24/2017

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: 07/31/2018
• Device Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MU2341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2017
• Initial Report FDA Received Date: 05/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1