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	03/21/2017
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 high blood glucose test results.The customer is concerned with tests results from results obtained of 234 mg/dl.The customer's expected fasting blood glucose test result range is 90 - 120 mg/dl.The customer is testing four times a day (fasting).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) 2017, a back to back blood test was performed by the customer fasting and produced test results of 236 mg/dl and 241 mg/dl using truemetrix air meter.The product is stored according to specification in the living room.The test strip lot manufacturer's expiration date is 04/30/2018 and open vial date is (b)(6) 2017.The customer stated he has not made any recent changes in his diet, exercise regimen and/or medication.The meter memory was reviewed for previous test result history: 1:234 mg/dl (b)(6) 2017 02:57 pm; fasting:yes.2:226mg/dl 03/20/2017 12:49 pm fasting:yes 3:224mg/dl 03/19/2017 04:14 pm fasting:yes 4:211mg/dl 03/19/2017 12:09 pm fasting:yes 5:215mg/dl 03/18/2017 08:42 pm fasting:yes memory concerns: the customer is concerned with these result: 234 mg/dl on 3/20/2017 @ 2:57 pm, 226 mg/dl on 3/20/2017 @ 12:49 pm and 224 mg/dl on 3/19/2017 @ 4:14 pm.The customer feels that the results he is getting from the meter are reading too high.

• 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: 6483116
• Report Number: 1000113657-2017-00652
• Device Sequence Number: 19132327
• Product Code: NBW
• UDI-Device Identifier: 00010939742445
• UDI-Public: (01)00010939742445
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 04/11/2017

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: 04/30/2018
• Device Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MT2203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2017
• Initial Report FDA Received Date: 04/11/2017
• 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