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	Headache (1880)
Date of Event	02/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report # (b)(4).Returned meter evaluated with no defect found.Test strips not returned for evaluation.Most likely underlying root cause: mlc-18- user has high glucose value test strip udi# (b)(4).At call back on (b)(6) 2018 the customer's condition had improved and she did not currently have any diabetic symptoms.No medical intervention had been needed since the last call.
Event or Problem Description
Consumer reported complaint for erratic blood glucose test results.The customer is concerned with tests results from back to back blood tests of 585 and 413 mg/dl.Customer stated she is unsure of what her expected glucose test result range should be.Customer is not concerned results are high, only that they are erratic.Customer only started to use the truemetrix air meter on (b)(6) 2018.Customer stated she had not been testing and had not been able to control her diabetes.Customer stated she had gone to the doctor on (b)(6) 2018 for her regular blood test and was told her blood glucose was high.Customer did not remember what the results were when at the doctor.At the time of the call, the customer reported having a headache; customer did not need medical attention at the time of the call.During the call on (b)(6) 2018, a back to back blood test was performed by the customer fasting and produced test results of 544 mg/dl and hi using truemetrix air meter.The product is stored according to specification in the bedroom.The test strip lot manufacturer's expiration date is 05/31/2019 and open vial date is 02/17/2018.The meter memory was reviewed for previous test result history: (b)(6).

• 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: 7336116
• Report Number: 1000113657-2018-00297
• Device Sequence Number: 213355
• Product Code: NBW
• UDI-Device Identifier: 00021292007010
• UDI-Public: (01)00021292007010
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 03/13/2018

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: 05/31/2019
• Device Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MU2708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2018
• Initial Report FDA Received Date: 03/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1