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); Sweating (2444)
Date of Event	12/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not returned for evaluation.No replacement product needed at this time.Product is working as designed.Most likely underlying root cause: mlc-18- user has high glucose value test strip udi# (b)(4).Unable to contact the customer via telephone at call backs on (b)(6) 2017.At call back on (b)(6) 2017, the customer's condition had not improved and she reported symptoms of numbness and pressure around her head.Customer stated she was going to seek medical attention and would follow-up once released.The customer also reported medical intervention since the initial call.Customer stated that she had gone to the hospital on (b)(6) 2017.The customer's blood glucose result when at the hospital was 703 mg/dl.The hospital diagnosis had been hyperglycemia and the customer was given insulin.The customer left the hospital on (b)(6) 2017 and a new medication had been suggested by a healthcare professional - janucet.Customer reported that the truemetrix air meter was still reading hi.At call back on (b)(6) 2017, the customer's condition had improved and she did not currently have any diabetic symptoms.Customer stated that she did not seek any medical attention since the last call.There were no additional blood tests performed with the truemetrix air meter.
Event or Problem Description
Consumer reported complaint for hi blood glucose test results.Nurse is calling on behalf of the customer.The customer is concerned with test results from results obtained of hi.The customer's expected blood glucose test result range was undisclosed.At the time of the call the customer reported feeling sweaty and dizzy; customer was going to seek medical attention.During the call on (b)(6) 2017, a back to back blood test was not performed by the customer.The product storage was undisclosed.The test strip lot manufacturer's expiration date is 05/14/2018 and open vial date was undisclosed.The meter memory was not reviewed for previous test result history.Customer called in states the meter is reading hi.Customer states the need for medical attention at the time of call and is having signs and symptoms of hyperglycemia at the time of call.

• 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: 7154608
• Report Number: 1000113657-2017-02125
• Device Sequence Number: 11081321
• Product Code: NBW
• UDI-Device Identifier: 00011822590051
• UDI-Public: (01)00011822590051
• 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: health professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/29/2017

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: 05/14/2018
• Device Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MT2215
• 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: 12/07/2017
• Initial Report FDA Received Date: 12/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1