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	05/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause 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.(b)(4).
Event or Problem Description
Consumer reported complaint for high blood glucose test results.Customer stated that he took his meter to the doctor (customer had a previous appointment) and they ran a blood test and compared it with their meter and the true metrix meter was giving higher results (comparison results not provided).The customer is concerned with test results from results obtained of 151 mg/dl.The customer's expected fasting blood glucose test result range is 86 - 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) 2017, a back to back blood test was not performed by the customer.The product storage was undisclosed.The test strip lot manufacturer's expiration date is 04/30/2018 and customer stated strips have been open for about three - four months.The meter memory was reviewed for previous test result history (date/time not set):128mg/dl (b)(6) 2016 06:35 pm fasting: yes; 151mg/dl (b)(6) 2016 06:09 pm fasting: yes; 136mg/dl (b)(6) 2016 06:04 pm fasting: yes; 128mg/dl (b)(6) 2016 06:21 pm fasting: yes;129mg/dl (b)(6) 2016 01:59 pm fasting: yes.Memory concerns: customer is concern with all these results.Customer calling states that meter is not giving accurate results.The results are too high.Customer states that the meter is giving about 20-60mg/dl higher than the true results meter.

• 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: 6591393
• Report Number: 1000113657-2017-00904
• Device Sequence Number: 13479111
• Product Code: NBW
• UDI-Device Identifier: 00087701427398
• UDI-Public: (01)00087701427398
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/25/2017

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: MT2214
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2017
• Initial Report FDA Received Date: 05/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1