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

Model Number	METRIX AIR
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Codes	Blurred Vision (2137); Urinary Frequency / Polyuria (2275); Polydipsia (2604)
Date of Event	12/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Customer call was disconnected ; unable to send replacement product and unable to make contact with her on follow-up attempts.No address on file for customer.Most likely underlying root cause: mlc-58-user had an inaccurate reference: self: the person is using themselves as the reference or how they feel at the time they run the blood test.Test strip udi# (b)(4).Note: unable to contact the customer via telephone at call backs on (b)(6) 2018, (b)(6) 2018 and (b)(6) 2018.Unable to send product notification letter as no address on file for customer.
Event or Problem Description
Call was transferred due to customer stating she was having symptoms of frequently urinating, had excessive thirst, blurry vision, and was feeling weak/tired.Customer was informed that these are symptoms of hyperglycemia and to seek medical attention.Customer was instructed several times to call 911 and stated that she will not go unless she obtains a result.Customer stated she got a result of 108 mg/dl and wanted to know if that is correct.Customer was informed due to her symptoms, it seems her blood sugar is elevated and to call 911 or to reach out to her doctor's office.No further information was able to be obtained.Initial call had been disconnected, attempts to contact customer on (b)(6) 2018, were made, but were unable to reach customer.

• 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: 8212611
• Report Number: 1000113657-2019-00010
• Device Sequence Number: 16634546
• Product Code: NBW
• UDI-Device Identifier: 00021292007447
• UDI-Public: (01)00021292007447
• 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): 01/03/2019

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: 10/13/2019
• Device Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MV2855
• 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: 12/12/2018
• Initial Report FDA Received Date: 01/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1