MAUDE Adverse Event Report: TRIVIDIA HEALTH, INC. METRIX AIR; BLOOD GLUCOSE SYSTEM

Model Number	METRIX AIR
Medical Device Problem Codes	Low Test Results (2458); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypoglycemia (1912); Dizziness (2194)
Date of Event	08/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned meter and returned test strips evaluated with no defects found.Most likely underlying root cause: mlc-56-user had an inaccurate reference: lab results: the end user is comparing results obtained from trividias's bgm system to the results from the laboratory (b)(4).Manufacturer contacted customer on (b)(6) 2018 in a follow-up call to ensure that the replacement products resolved the initial concern; customer stated that the replacement product is working to their satisfaction and they have not had any medical intervention or symptoms since the last call.
Event or Problem Description
Consumer reported complaint for low blood glucose test results.Humana representative, with customer on the line, is calling on behalf of the customer.The customer is concerned with tests results of 40 mg/dl fasting and meter to lab comparison results of 104 mg/dl non-fasting using truemetrix air meter and 285 mg/dl non-fasting from doctor's lab.The customer's expected fasting blood glucose test result range is 90 - 100 mg/dl.At the time of the call, the customer felt well and did not report any symptoms.Customer stated that in (b)(6) (customer did not remember exact date) had felt dizzy and lightheaded.Customer had performed a blood test fasting using the truemetrix air meter and obtained a result of 60 mg/dl.Customer stated she had gone to the er.Customer was diagnosed with hypoglycemia and was given orange juice.Customer did not remember her blood glucose test result when at the er.The er doctor had advised the customer to stop taking metformin and victoza.Customer was at the er for two hours before being released the same day.Customer had continued to use the truemetrix air meter.During the call on (b)(6) 2018, a back to back blood test was performed by the customer fasting and produced test results of 92 mg/dl and 97 mg/dl using truemetrix air meter.The product is stored according to specification in the bedroom.The test strip lot manufacturer's expiration date is 07/17/2019 and open vial date is (b)(6) 2018.The meter memory was reviewed for previous test result history: result 1 :40 mg/dl date: (b)(6) 2018 time:3:00 pm fasting, result 2 :104mg/dl date: (b)(6) 2018 time:7:10pm fasting, result 3 :100mg/dl date: (b)(6) 2018 time:7:15am fasting, result 4 : 90mg/dl date: (b)(6) 2018 time: 7:25am fasting, result 5 :100mg/dl date: (b)(6) 2018 time:4:50am 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: 7857007
• Report Number: 1000113657-2018-00935
• Device Sequence Number: 13814272
• Product Code: NBW
• UDI-Device Identifier: 00021292007584
• UDI-Public: (01)00021292007584
• Combination Product (Y/N): N
• Initial Reporter State: NE
• PMA/510(K) Number: K150052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/17/2019
• Device Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MV2749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 09/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1