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

Model Number	METRIX AIR
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Fainting (1847); Loss of consciousness (2418); Sweating (2444)
Date of Event	03/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) (b)(4).Returned meter evaluated with defect found.On the qc investigation on 3/28/2018 meter was not operational.Final root cause : user induced pcb contamination.Test strip (b)(4).Note: manufacturer contacted customer on 3/13/2018 in a follow-up call in order 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 on (b)(6) 2018.
Event or Problem Description
Consumer initially reported complaint for dead meter.However on follow up call on 3/13/2018 he reported symptoms and medical attention.Customer states that on (b)(6) 2018, he had taken blood result on old meter (ta0408337) and it worked.Later on, he took his regular medication of humolog and lantus.His wife found customer unresponsive and she called out to him and no response.He was sweaty and clammy.The paramedics were called between 11:00 pm and 12:00 am.They came within 5 minutes.Paramedics came, and took his blood sugar and the result was 27 mg/dl.He was given iv with sugar and then he was ok within 10 minutes.They ask him questions and he was able to answer.The paramedics took his blood result before leaving and the result was above 100 mg/dl.He did not go to the hospital.His wife later gave him 2 peanut butter sandwiches.Customer normally takes this medication 4x a day on a sliding scale.Customer says he called them due to his diabetes.No diabetic symptoms now and he is feeling well.On the (b)(6) he tried to test with old meter and it was dead.The expected fasting blood glucose test result range is 83 mg/dl.The product storage location is undisclosed.The test strip lot manufacturer's expiration date is 01/31/2019 and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.Customer didn't mention the adverse event on the initial call on (b)(6) 2018.

• 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: 7383816
• Report Number: 1000113657-2018-00378
• Device Sequence Number: 2312553
• Product Code: NBW
• UDI-Device Identifier: 00021292007911
• UDI-Public: (01)00021292007911
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/29/2018

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 Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MU2567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2018
• Initial Report FDA Received Date: 03/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1