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	01/15/2018
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-20-user's test strip had poor storage.Test strip udi# (b)(4).Note: manufacturer contacted customer on 1/23/2018 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 since the last call.
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with test results from results obtained of 280 mg/dl (fasting); the customer did not remember when this result was taken and did not see it in the meter memory.The customer's expected fasting blood glucose test result range is 90 - 120 mg/dl.Customer is pregnant.The customer feels well and did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results.Customer also stated that she is comparing the results of the truemetrix air meter against another handheld meter; actual meter to meter comparison results were not provided.During the call on (b)(6) 2018 , a back to back blood test was not performed by the customer.The product is not stored according to specification and is being stored in customer's purse.The test strip lot manufacturer's expiration date is 02/16/2019 and open vial date is december 2017.The meter memory was reviewed for previous test result history (customer is not concerned with the results of 77 or 85 mg/dl): (b)(6).The customer is concerned with this result: the customer is concerned with a result of 280 mg/dl (fasting), customer does not know remember when the result was taken and does not see it in the meter.The customer is not concerned with the result of 77 mg/dl or 85 mg/dl.

• 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: 7241024
• Report Number: 1000113657-2018-00142
• Device Sequence Number: 1157829
• Product Code: NBW
• UDI-Device Identifier: 00021292007010
• UDI-Public: (01)00021292007010
• 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): 02/05/2018

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: 02/16/2019
• Device Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MU2588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2018
• Initial Report FDA Received Date: 02/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1