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

Model Number	METRIX AIR
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Codes	Dizziness (2194); Polydipsia (2604)
Date of Event	09/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not returned for evaluation.No replacement product at this time.Test strips are expired.Most likely underlying root cause: mlc-22-client is testing with expired test strips test strip udi# (b)(4).Note: manufacturer contacted customer (several attempts) in a follow-up call in order to ensure the customer's condition since the initial call - unable to establish contact with the customer at this time.Product notification letter sent to customer to contact customer care.
Event or Problem Description
Consumer reported complaint for e-0 accompanied by symptoms.The expected fasting blood glucose test result range is undisclosed.Customer did report symptoms of feeling light headed and dry mouth.Medical attention is not reported as a result of the actual blood glucose results and reported symptoms.The product storage location is undisclosed.Test strip lot manufacturer's expiration date is 08/29/2017 (expired) and open vial date is 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: 7996618
• Report Number: 1000113657-2018-01092
• Device Sequence Number: 16250260
• 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): 10/23/2018

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 Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MT1663
• 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: 09/28/2018
• Initial Report FDA Received Date: 10/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1