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	02/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) (b)(4).Product not yet returned for evaluation.Most likely underlying root cause of malfunction: user had an inaccurate reference.Test strip (b)(4).
Event or Problem Description
Consumer reported complaint for low blood glucose test results.The customer is concerned with tests results from results obtained of 80, 69 and 58 mg/dl.The customer's expected fasting blood glucose test result range is 75 - 125 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.Customer stated he has been getting high results as well but is more concerned with the low results.During the call on (b)(6) 2017, a back to back blood test was not performed by the customer; customer had just eaten.The product is stored according to specification.The test strip lot manufacturer's expiration date is 01/27/2018 and open vial date is month of (b)(6) 2017.Customer stated he takes his blood test fasting in the mornings and the evenings.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 meters memory he takes his blood test fasting in the mornings and the evenings.He has been getting high results as well but is more concerned with the lows.He said when he got the low results he was not having any low symptoms.He would start to feel glarey eyed below 70 mg/dl and he was not.

• 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: 6425077
• Report Number: 1000113657-2017-00535
• Device Sequence Number: 13728704
• Product Code: NBW
• UDI-Device Identifier: 00052569139042
• UDI-Public: (01)00052569139042
• 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: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/22/2017

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: 01/27/2018
• Device Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MT1901
• 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: 02/25/2017
• Initial Report FDA Received Date: 03/22/2017
• 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