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

Model Number	METRIX AIR
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/31/2016
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 fill.(b)(4).
Event or Problem Description
Consumer reported complaint for low blood glucose test results.(b)(6) is calling on behalf of the customer.The customer is concerned with tests results from results obtained of 60 and 79 mg/dl.The customer's expected fasting blood glucose test result range is 80 - 100 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) 2016, a back to back blood test was performed by the customer non-fasting and produced test results of 152 mg/dl and 154 mg/dl using truemetrix air meter.The product is stored according to specification.The test strip lot manufacturer's expiration date is 03/28/2017 and open vial date is month of (b)(6) 2016.The customer had not had any changes in his diet or exercise regimen and takes lantus to manage his diabetes.The meter memory was reviewed for previous test result history: (b)(6).Memory concerns:the customer is concerned with the 5 results provided in the meter's memory.

• 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: 6279154
• Report Number: 1000113657-2017-00123
• Device Sequence Number: 1075590
• Product Code: NBW
• UDI-Device Identifier: 00021292007164
• UDI-Public: (01)00021292007164
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 01/26/2017

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: 03/28/2017
• Device Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MT1499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2016
• Initial Report FDA Received Date: 01/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SECOND THERAPY