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	01/01/2017
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 had an inaccurate reference.(b)(4).
Event or Problem Description
Consumer reported complaint for low blood glucose test results.The customer is concerned with tests results from all of the results obtained.The customer's expected fasting blood glucose test result range is 130 to 150mg/dl.The customer feels well and did not report any symptoms.The product is stored according to specification.Medical attention is not reported as a result of the actual blood glucose results.During the call on (b)(6) 2017, a back to back blood test was performed by the customer fasting and produced test results of 131 and 139mg/dl using true metrix air meter.The test strip lot manufacturer's expiration date is 01/01/2017 and open vial date is within the month of (b)(6) 2016.The meter memory was reviewed for previous test result history: (b)(6).Memory concerns: the customer is concerned with results of 115,112, 79 and 113mg/dl in the meter's memory.The customer is calling in regards to getting low results on the meter when she performs her blood test.The customer is not having any symptoms of low blood sugar now.She is feeling well.She takes her blood test fasting in the mornings.She takes lantus and metformin to manage her diabetes.The customer is concerned with low results she had gotten before 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: 6279214
• Report Number: 1000113657-2017-00124
• Device Sequence Number: 1129177
• Product Code: NBW
• UDI-Device Identifier: 00021292007164
• UDI-Public: (01)00021292007164
• 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): 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 Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MT1682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/01/2017
• 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