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); Shaking/Tremors (2515)
Date of Event	09/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) internal report # (b)(4).Product not yet returned for evaluation.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 (b)(4).
Event or Problem Description
Consumer reported complaint for high accompanied by symptoms.The customer is concerned with results obtained of 175, 197, 264 and 261mg/dl.The expected fasting blood glucose test result range is 150mg/dl.The customer did report symptoms of blurry vision, feeling fatigue and shaky.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 closet.During the call on (b)(6) 2018, a back to back blood test was performed non-fasting by the customer and produced test results of 230 and 245mg/dl using true metrix air meter.The test strip lot manufacturer's expiration date is 03/19/2020 and open vial date is (b)(6) 2018.The meter memory was reviewed for previous test result history: (b)(6).Customer states that he feels ill- he has blurry vision, feeling fatigue, shaky.Customer is concerned with results being higher than his expected range.Customer states that two weeks ago, the meter was reading over 200mg/dl.Customer called the doctor office and told them about it.They scheduled for him to go do some labs, which he states he did days after.After the doctors received his labs, they told him to come into the office and they scheduled an appointment for him.The customer does not remember exactly but believes that he went to the doctor's office (b)(6) 2018.At the doctor's office, they checked his blood sugar; customer does not remember the results.However, he states that the doctors were concerned with his labs.They made changes to his medication.Customer sates that on that day, he went home to realize that he was testing with expired test strips.The lot number was mt1867.Customer stop testing until he received new products.This morning customer used the new vial of test strips to test and was concerned with the result being too high.Customer then used one of the expired test strips which tested lower than the new strips.Educated customer not to use expired products.

• 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: 7924192
• Report Number: 1000113657-2018-00987
• Device Sequence Number: 11144591
• Product Code: NBW
• UDI-Device Identifier: 00021292007010
• UDI-Public: (01)00021292007010
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 10/01/2018

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: MV2930
• 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: 09/06/2018
• Initial Report FDA Received Date: 10/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1