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

Model Number	METRIX AIR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fatigue (1849); Headache (1880); Blurred Vision (2137)
Date of Event	04/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not returned for evaluation.No replacement product needed at this time.There was no complaint on the product performance.Customer call was a training call.Most likely underlying root cause: mlc-28-there was not enough information to determine the mlurc test strip udi# (b)(4).Note: several call back's attempts were made by manufacturer to ensure the customer's condition since the initial call; unable to establish contact with the customer at this time.Unable to send product notification letter as no address on file.Manufacturer contacted customer on (b)(4) 2018 in a follow-up call to ensure the customer's condition since the initial call; customer condition worsen.Customer report symptoms of fatigue, blurred vision also kidney pain and customer states has hypoglycemic symptoms such as feeling clammy.Customer continued to use meter and its receiving high and low readings.Customer states she spoke to her physician and is aware of her symptoms undisclosed date when she spoke to her physician which will refer her to an endocrinologist and optometrist.Customer states that her medication was changed.See section b for details.To address the new complaint of low and high readings a new complaint (b)(4) was created.
Event or Problem Description
Customer called for assistance with setting time and date.At the time of the call, the customer reported symptoms of headache and blurry vision.No medical attention was reported at the time of the call.Customer stated she would call her doctor.Customer disconnect the call.

• 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: 7535034
• Report Number: 1000113657-2018-00577
• Device Sequence Number: 16186923
• Product Code: NBW
• UDI-Device Identifier: 00041220009169
• UDI-Public: (01)00041220009169
• 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): 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/16/2019
• Device Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MU2587
• 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: 04/26/2018
• Initial Report FDA Received Date: 05/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1