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 Codes	Dizziness (2194); Polydipsia (2604)
Date of Event	10/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) (b)(4).Product not returned for evaluation.No replacement product needed at this time.Complaint resolved by training during the time of the call.Product is working as designed.Most likely underlying root cause: mlc-18- user has high glucose value.Test strip (b)(4).Note: after several attempts manufacturer contacted customer on 10/18/2017 in a follow-up call in order to ensure the customer's condition since the initial call; customer's condition had improved.On (b)(6) 2017, the customer had taken 40 units of humalog at 9:45 pm.Due to the hi result obtained and the customer feeling dizzy, an ambulance was called and brought the customer to the hospital.The customer was admitted to the hospital at 10:30 pm on (b)(6) 2017.When admitted to the hospital the customer was dizzy and had excessive thirst.The customer's blood glucose test result when at the hospital was over 700 mg/dl (hospital laboratory).The hospital diagnosis was hyperglycemia and the customer received an insulin drip.The customer left the hospital on (b)(6) 2017.No additional blood tests were performed with the truemetrix air meter as the customer had run out of test strips.
Event or Problem Description
Consumer reported complaint for e-5.The e-5 error occurred as soon as the blood sample was absorbed.During the call on (b)(6) 2017, a blood test was performed by the customer and produced test result of hi.The customer's expected blood glucose test result range was undisclosed.At the time of the call the customer reported feeling dizzy and stated they would go to the er.The product storage was undisclosed.The test strip lot manufacturer's expiration date is 02/17/2018 and open vial date is (b)(6) 2017.The meter memory was not reviewed for previous test result history.

• 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: 6998970
• Report Number: 1000113657-2017-01899
• Device Sequence Number: 1549041
• Product Code: NBW
• UDI-Device Identifier: 00021292007911
• UDI-Public: (01)00021292007911
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 11/03/2017

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: 02/17/2018
• Device Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MT1941
• 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: 10/12/2017
• Initial Report FDA Received Date: 11/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization