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	02/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report # (b)(4).Product not yet returned for evaluation.Most likely underlying root cause of malfunction: user's test strip had poor storage (kitchen).Test strip udi# (b)(4).
Event or Problem Description
Consumer reported complaint for high 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 79 to 110mg/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.The product is not stored according to specification in the kitchen.The test strip lot manufacturer's expiration date is 04/24/2018 and open vial date is 2/3/2017.The meter memory was reviewed for previous test result history: the 157mg/dl (b)(6) 2017 07:31 am fasting: yes, the 135mg/dl (b)(6) 2017 09:41 pm fasting: no, the 110mg/dl (b)(6) 2017 11:14 am fasting: yes, the 139mg/dl (b)(6) 2017 10:51 pm fasting: yes, the 318mg/dl (b)(6) 2017 11:38 pm fasting: yes.Customer states she manages her diabetes with diet and exercise and has not had any recent changes in her daily routine.Customer is concerned with all readings obtained with meter, especially the reading obtained (b)(6) 2017 at 11:38 pm of 318mg/dl fasting.
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) (b)(4).Returned meter and returned test strips evaluated with no defects found.Most likely underlying root cause of malfunction: user's test strip had poor storage (kitchen).Test strip (b)(4).
Event or Problem Description
Consumer reported complaint for high 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 79 to 110 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.The product is not stored according to specification in the kitchen.The test strip lot manufacturer's expiration date is 04/24/2018 and open vial date is (b)(6) 2017.The meter memory was reviewed for previous test result history: (b)(6).Customer states she manages her diabetes with diet and exercise and has not had any recent changes in her daily routine.Customer is concerned with all readings obtained with meter, especially the reading obtained (b)(6) 2017 at 11:38 pm of 318 mg/dl fasting.

• 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: 6409517
• Report Number: 1000113657-2017-00498
• Device Sequence Number: 918629
• Product Code: NBW
• UDI-Device Identifier: 00041220009169
• UDI-Public: (01)00041220009169
• 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,Followup
• Report Date (Section B): 03/24/2017

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: MT2139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/20/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2017
• Supplement Report FDA Received Date: 03/24/2017
• 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