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

Model Number	METRIX AIR
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	Fatigue (1849)
Date of Event	02/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not returned for evaluation.No replacement product needed at this time.Customer will buy new test strips.Test strips are expired.Most likely underlying root cause: mlc-22- client is testing with expired test strips test strip udi# (b)(4).At call back on (b)(6) 2018, customer stated her condition remained the same.No medical intervention was reported since the last call.Customer had not yet purchased new test strips.Unable to contact the customer via telephone at call backs on (b)(6) 2018.Unable to send product notification letter as no address on file for customer.
Event or Problem Description
Consumer reported complaint for e-2 error: sample not detected or using wrong test strip.The e-2 error occurred after the blood sample was applied.Customer was using the correct test strips.Customer had two different lots of test strips but both lots were expired: ms1484, manufacturer's expiration date of 06/19/2017 and ms1332, manufacturer's expiration date of 08/18/2016.Customer was advised to discard expired product.Customer was going to purchase new test strips.The customer's expected blood glucose test result range was undisclosed.At the time of the call the customer reported feeling tired and believed it to be due to her diabetes.Customer did not need medical attention at the time of the call.During the call on (b)(6) 2018, a blood test was not performed by the customer as test strips were expired.The product storage was undisclosed.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: 7345110
• Report Number: 1000113657-2018-00317
• Device Sequence Number: 592067
• Product Code: NBW
• UDI-Device Identifier: 00311917173894
• UDI-Public: (01)00311917173894
• 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): 03/16/2018

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: 06/19/2017
• Device Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MS1484
• 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: 02/20/2018
• Initial Report FDA Received Date: 03/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1