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	Blurred Vision (2137); Urinary Frequency / Polyuria (2275); Polydipsia (2604)
Date of Event	11/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned meter evaluated with no defect found.Test strips not returned for evaluation most likely underlying root cause: mlc-18- user has high glucose value.(b)(4).Note: manufacturer contacted customer on 12/1/2017 in a follow-up call in order to ensure the customer's condition since the initial call; customer's condition has improved and she is no longer experiencing any diabetic symptoms.However, she did seek medical attention on (b)(6) 2017 for a blood glucose reading of 283mg/dl.No treatment was provided.She was diagnoses with hyperglycemia due to stress and was told to continue taking her medication.She was discharged the same day.
Event or Problem Description
Consumer reported complaint for hi blood glucose results accompanied by symptoms.The expected fasting blood glucose test result range is 85-105mg/dl.The customer did report symptoms of blurry vision, frequent urination and dry mouth.Medical attention is reported as a result of the actual blood glucose results and reported symptoms.The product is stored by customer according to specification in the bedroom.The test strip lot manufacturer's expiration date is 08/31/2018 and open vial date is (b)(6) 2017.The meter memory was reviewed for previous test result history: result 1 :415mg/dl date:(b)(6) 2017 time:8:51am fasting, result 2 :hi date:(b)(6) 2017 time:8:48am fasting, result 3 :404mg/dl date:(b)(6) 2017 time:8:09am fasting, result 4 :381mg/dl date:(b)(6) 2017 time:7:51am fasting, result 5 :81mg/dl date:(b)(6) 2017 time:11:46pm fasting.Customer called in for assistance with e-2 error message, while troubleshooting we obtained a reading of hi, requested customer run another test on a different finger and customer obtained 415mg/dl, both readings are fasting.Customer states that for the past couple of days she has been urinating more frequently.Customer states that today she felt dry mouth upon awakening and is now experiencing blurry vision.Customer denied the need to seek medical attention.I reinforced the urge for customer to seek medical attention.Customer states she will call her niece to take her to the clinic after the phone call.Customer states that back in (b)(6) 2017, while using a different brand meter, she had really high readings due to personal stress and other issues and was working closely with her doctor to lower these numbers.Customer went to routine doctor visit and explained that the doctor increased her dose of metformin and had also put her on glipizide and customer confirmed that this helped her lower her sugar.Customer states she purchased the true metrix in (b)(6) 2017 and states that since (b)(6) she has lowered her fasting range from the high 300's and 400's mg/dl to a steady 85-105mg/dl.Customer states she is not concerned with the high numbers on the meter since she is experiencing symptoms of hyperglycemia.

• 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: 7139955
• Report Number: 1000113657-2017-02103
• Device Sequence Number: 18849233
• 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): 12/21/2017

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 Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MU2382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 12/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1