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 Codes	Fatigue (1849); Blurred Vision (2137)
Date of Event	09/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report # (b)(4).Product not returned for evaluation.No replacement product needed at this time.Product is working as designed.Most likely underlying root cause: mlc-18- user has high glucose value test strip udi# (b)(4).Note: manufacturer contacted customer on 9/21/2018 in a follow-up call to ensure the customer's condition since the initial call; customer's condition had improved and she did not currently have any diabetic symptoms.Customer stated she had contacted physician on (b)(6) 2018; customer stated physician advised her to monitor her blood sugar level.During the call back on (b)(6) 2018, a blood test was performed by the customer fasting using truemetrix air meter and produced test result of hi.The test strip lot manufacturer's expiration date is 09/29/2019 and open vial date is (b)(6) 2018.The customer had disconnected the call; call back attempt made to customer and voicemail was left.Product notification letter sent to customer to contact customer care.
Event or Problem Description
Consumer initially reported complaint for e-5 error: test strip error.At the time of the call, the customer reported feeling ill with symptoms of blurry vision and fatigue.Customer was going to seek medical attention and was not able to continue with the troubleshooting process.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: 7960363
• Report Number: 1000113657-2018-01024
• Device Sequence Number: 13873440
• Product Code: NBW
• UDI-Device Identifier: 00021292007911
• UDI-Public: (01)00021292007911
• 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): 10/12/2018

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: 09/29/2019
• Device Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MV2837
• 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: 09/18/2018
• Initial Report FDA Received Date: 10/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1