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	10/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not returned for evaluation.No replacement product needed at this time.Customer want to call her dr.First.Most likely underlying root cause: mlc-18- user has high glucose value.Test strip udi# (b)(4).Manufacturer contacted customer (several attempts) in a follow-up call to ensure that the initial concern was resolved- unable to establish contact with the customer at this time.Product notification letter sent to customer to contact customer care.Unable to send product notification letter as no address on file.
Event or Problem Description
Consumer reported complaint for hi blood glucose test results.The customer is concerned with tests results from results obtained of hi.The customer feels well and did not report any symptoms.Customer stated that she was going to call her doctor in order to determine how much medication to take.No further information was able to be obtained.

• 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: 8089948
• Report Number: 1000113657-2018-01191
• Device Sequence Number: 1326778
• Product Code: NBW
• UDI-Device Identifier: 00021292007584
• UDI-Public: (01)00021292007584
• 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): 11/20/2018

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: 01/21/2019
• Device Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MU2561
• 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: 10/30/2018
• Initial Report FDA Received Date: 11/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1