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); Vertigo (2134); No Code Available (3191)
Date of Event	05/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-18- user has high glucose value test strip udi# (b)(4).Note: manufacturer contacted customer (several attempts) in a follow-up call to ensure that the replacement products resolved the initial concern and 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 high blood glucose results.The customer is concerned with all the results obtained.The expected fasting blood glucose test result range is 200-230 mg/dl.The customer did report symptoms of feeling clammy, fatigue, blurry vision and kidney pain.Medical attention is not reported as a result of the actual blood glucose results and reported symptoms.The product is stored by customer according to specification in the living room.During the call on (b)(6) 2018, a back to back blood test was declined by the customer.The test strip lot manufacturer's expiration date is 11/26/2018 and open vial date is (b)(6) 2018.The meter memory was reviewed for previous test result history: (date/time not stored correctly): (b)(6).Customer called in states the meter is reading high blood results.Customer states her normal fasting range is 200mg/dl-230mg/dl fasting and a1c 11 (269mg/dl).Customer denies the need for medical attention at the time of call and has signs and symptoms of hypoglycemia or hyperglycemia.Hyperglycemic symptoms, fatigued, blurred vision and also kidney pain and customer states and hypoglycemic symptoms such as feeling clammy.Customer will follow up with hospital and healthcare provider.Doctor is aware of symptoms.Customer states she spoke to her physician and is aware of her symptoms.Physician refer her to an endocrinologist and optometrist.

• 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: 7562205
• Report Number: 1000113657-2018-00609
• Device Sequence Number: 1317647
• Product Code: NBW
• UDI-Device Identifier: 00041220009169
• UDI-Public: (01)00041220009169
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Replace
• Type of Report: Initial
• Report Date (Section B): 06/01/2018

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: MU2484
• 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: 05/08/2018
• Initial Report FDA Received Date: 06/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1