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	09/17/2018
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: mlc-58-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).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 high and erratic blood glucose test results.The customer is concerned with tests results of 263, 275, 195, 209 and 229 mg/dl.The customer's expected fasting blood glucose test result range is 100 - 150 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) 2018, a back to back blood test was performed by the customer non-fasting and produced test results of 242 mg/dl and 237 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 10/23/2019 and open vial date is (b)(6) 2018.The meter memory was reviewed for previous test result history (customer could not really see the date/time, and so he provided the information he thinks he sees; also customer stated that he has never set up the date/time): result 1 :263mg/dl date: (b)(6) 2018 time: 01:00pm fasting; result 2 :275mg/dl date: (b)(6) 2018 time: 01:00pm fasting; result 3 :195mg/dl date: (b)(6) 2018 time: 03:00pm fasting; result 4 :209mg/dl date: (b)(6) 2018 time: 04:00am fasting; result 5 :229mg/dl date:undisclosed time: undisclosed 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: 7931525
• Report Number: 1000113657-2018-00996
• Device Sequence Number: 1346804
• Product Code: NBW
• UDI-Device Identifier: 00021292007584
• UDI-Public: (01)00021292007584
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 10/03/2018

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: 10/23/2019
• Device Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MV2864
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2018
• Initial Report FDA Received Date: 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1